Objective To put forward some suggestions for improving the registration and regulation,the efficiency of evaluation,and approval of biosimilar in China so as to promote the development of biopharmaceutical industry a...Objective To put forward some suggestions for improving the registration and regulation,the efficiency of evaluation,and approval of biosimilar in China so as to promote the development of biopharmaceutical industry and increase the accessibility of therapeutic drugs in China.Methods Literature related to the registration and regulation,evaluation and approval of biosimilars were sorted out to analyze the differences in China and the USA.Results and Conclusion Based on the analysis of the current situation of registration and regulation of biosimilars between China and the USA,it is suggested to improve the registration and regulation of biosimilars in China from the following four aspects:Establishing a biosimilar regulatory department,expanding the professional evaluation personnel,scientifically simplifying the registration and approval procedures,and constantly refining the types of communication meetings.展开更多
A biologic drug is a medication produced from or containing components of living organisms.Given the rigorous testing that originator biologics undergo to establish Food and Drug Administration(FDA)Biologics License A...A biologic drug is a medication produced from or containing components of living organisms.Given the rigorous testing that originator biologics undergo to establish Food and Drug Administration(FDA)Biologics License Application(BLA)approval,their subsequent price yields a high burden on healthcare systems(1).Biologics account for 37%of prescription drug spending,despite comprising only 2%of all prescribed medications(2).Biosimilar medicines are designed to have active properties that are“highly similar”to a previously licensed reference product,leading to increased chemistry,manufacturing,and controls(CMC).展开更多
BACKGROUND Over the last decade,the treatment options for inflammatory bowel disease(IBD)have significantly progressed with the emergence of new medications designed to target various immune pathways and mitigate infl...BACKGROUND Over the last decade,the treatment options for inflammatory bowel disease(IBD)have significantly progressed with the emergence of new medications designed to target various immune pathways and mitigate inflammation.Adalimumab(ADA)is a tumor necrosis factor alpha antagonist and stands as an effective treatment for IBD.In April 2021,the province of British Columbia implemented a mandatory non-medical switch policy of the ADA originator Humira®to ADA biosimilars.Biosimilars offer a potential cost-effective,safe,and efficacious alternative to the originator,yet there remains limited real-world evidence on long-term outcomes of ADA non-medical switching in IBD.AIM To assess the long-term outcomes of non-medical switching from the ADA originator Humira®to an ADA biosimilar among IBD patients.METHODS A retrospective observational chart review study was conducted on IBD patients eligible for the provincially mandated non-medical switch to an ADA biosimilar.The primary outcome was treatment persistence at 30 months post-switch.Secondary outcomes included the proportion of and reasons for therapy alteration or ADA discontinuation,loss of response(LOR)rates,adverse events(AE),and clinical and biochemical remission status.Patients who remained on the originator throughout the switch period,through compassionate support or private pay,constituted the comparison group.RESULTS Patients in the originator(n=43)and biosimilar switch(n=228)groups displayed similar demographics and baseline disease characteristics.By the study endpoint of 30 months,there was no difference in the rate of treatment persistence in either group(n=36,83.7%originator group vs n=201,88.2%biosimilar group,P=0.451).Treatment persistence demonstrated similar rates of discontinuation between both study groups(log-rank P=0.543).There was a numerical but not statistically significant difference in rates of adverse outcomes between either group(39.5%originator vs 28.9%biosimilars,P=0.206).This included comparable rates of LOR(27.9%vs 17.5%)or AE(11.6%vs 11.4%)between the originator and biosimilar cohorts,respectively.C-reactive protein and fecal calprotectin levels were similar one year pre-and post-switch.CONCLUSION These data support the long-term efficacy and safety of non-medical ADA switching in IBD and will help inform patients and physicians in jurisdictions currently undergoing biosimilar switching.展开更多
BACKGROUND Juvenile systemic lupus erythematosus(SLE)is a severe,life-threatening disease.However,the role of rituximab in managing juvenile SLE remains undefined,although early biological intervention may improve dis...BACKGROUND Juvenile systemic lupus erythematosus(SLE)is a severe,life-threatening disease.However,the role of rituximab in managing juvenile SLE remains undefined,although early biological intervention may improve disease outcomes.AIM To assess the differences in the outcomes of different types of rituximab administration(early and late).METHODS In this retrospective cohort study,the information of 36 children with SLE with administration(LRA)was analyzed.We compared initial disease characteristics at onset,at baseline(start of rituximab),and at the end of the study(EOS)at 12 months,as well as outcomes and treatment characteristics.RESULTS The main differences at baseline were a higher daily median dose of corticosteroids,increased MAS frequency,and a higher Systemic Lupus Erythematosus Disease Activity Index(SLEDAI)in the ERA group.No differences in the main SLE outcomes between groups at the EOS were observed.The part of lupus nephritis patients who achieved remission changed from 44%to 31%in ERA and 32%to 11%in the LRA group.Patients with ERA had a shorter time to achieve low daily corticosteroid dose(≤0.2 mg/kg)at 1.2(0.9;1.4)years compared to 2.8(2.3;4.0)years(P=0.000001)and higher probability to achieve this low dose[hazard ratio(HR)=57.8(95%confidence interval(CI):7.2-463.2),P=0.00001 and remission(SLEDAI=0);HR=37.6(95%CI:4.45-333.3),P=0.00001].No differences in adverse events,including severe adverse events,were observed.CONCLUSION ERA demonstrated a better steroid-sparing effect and a possibility of earlier remission or low disease activity,except for lupus nephritis.Further investigations are required.展开更多
Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods. A similar biologic drug, commonly called biosimilar, is a product copied by a native approved biologic drug who...Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods. A similar biologic drug, commonly called biosimilar, is a product copied by a native approved biologic drug whose license has expired. Biosimilar drugs usually are marketed at a lower price and provide important financial savings for public healthcare systems. Some differences between biosimilars and original biologic drugs might exist but they are acceptable if they fall within defined “boundaries of tolerance”: differences in some features between the two molecules are considered important only if clinical relevant. Considering that the efficacy of the innovator biologic drug has already been established, the clinical studies required for approval of a biosimilar could be reduced compared with those required for the approval of the originator. In this review, real life data available in inflammatory bowel disease patients treated with biosimilars are reported, documenting in general satisfactory outcomes, sustained efficacy and no sign of increased immunogenicity, although, further controlled data are awaited.展开更多
Objective: This study aimed to compare the pharmacokinetic, pharmacodynamic and safety profiles of HLX01(a rituximab biosimilar) and reference rituximab sourced from China(Mab Thera?;rituximab-CN).Methods: Here we rep...Objective: This study aimed to compare the pharmacokinetic, pharmacodynamic and safety profiles of HLX01(a rituximab biosimilar) and reference rituximab sourced from China(Mab Thera?;rituximab-CN).Methods: Here we report the results of two phase 1 studies. In the phase 1 a, open-label, dose-escalation study(NCT03218072, CTR20140400), eligible patients received 250, 375 and 500 mg/m^(2) HLX01 sequentially at 7-day intervals, after confirming no dose-limiting toxicity(DLT). In the phase 1 b, double-blind study(NCT02584920,CTR20140764), eligible patients were given a single dose of 375 mg/m^(2) HLX01 or rituximab-CN. The primary endpoints included safety and tolerability parameters for the phase 1 a and the area under the plasma concentrationtime curve from time zero to day 91(AUC0-91 d) for the phase 1 b study. Equivalence was concluded if 90%confidence interval(90% CI) for the geometric least squares mean ratio(GLSMR) fell in the pre-specified equivalence criteria(80%-125%).Results: Between June 20, 2014 and January 5, 2015, 12 patients were enrolled in the phase 1 a study. The pharmacokinetics of HLX01 showed dose proportionality and accumulation to steady state. HLX01 was well tolerated, with no serious adverse events(AEs), discontinuations or DLTs. Between November 8, 2014 and August13, 2015, 87 eligible patients were enrolled in the phase 1 b study, including 43 who received HLX01 and 44 who were treated with rituximab-CN. The equivalence endpoint was met with GLSMR for AUC0-91 d being 89.6%(90% CI: 80.4%-99.8%). AEs, anti-drug antibodies, and CD19+ and CD20+ B lymphocyte counts were similar between the HLX01 and rituximab-CN treatment groups.Conclusions: Treatment with HLX01 was safe and well tolerated in Chinese patients with B-cell lymphoma.HLX01 and rituximab-CN have similar pharmacokinetic, pharmacodynamic and safety profiles.展开更多
Biologic therapy, such as those that target tumor necrosis factor(TNF) signaling, has proven to be an efficacious method of treatment for patients with inflammatory bowel disease(IBD) with regards to symptom managemen...Biologic therapy, such as those that target tumor necrosis factor(TNF) signaling, has proven to be an efficacious method of treatment for patients with inflammatory bowel disease(IBD) with regards to symptom management and mucosal healing. However, the rising prevalence of IBD worldwide and the everincreasing burden of biologic pharmaceuticals in the health care industry is alarming for insurance companies, clinicians, and patients. The impending patent expiry and the relatively high costs of biologics, particularly anti-TNF agents, have paved the way for biosimilar development for IBD. The United States Food and Drug Administration defines a biosimilar as a biological product that is highly similar to its reference medicinal product, with no clinically meaningful differences in terms of safety, purity, and potency. The hope with biosimilars is that their entry into the market will be able to drive competition between pharmaceutical companies to reduce prices like that of the generic market, and that access to appropriate biologic treatments for IBD patients is increased in the long-term. Yet, there are challenging issues such as indication extrapolation and interchangeability that are still being debated in the field of IBD and must be addressed in future issued guidance. This review will discuss the issues and implications concerning the use of biosimilar therapy for IBD.展开更多
Biosimilars are a growing drug class designed to be used interchangeably with biologics.Biologics are cr-eated in living cells and are typically large,complex pr-oteins that may have a variety of uses.Within the field...Biosimilars are a growing drug class designed to be used interchangeably with biologics.Biologics are cr-eated in living cells and are typically large,complex pr-oteins that may have a variety of uses.Within the field of gastroenterology alone,biologics are used to treat inflammatory bowel diseases,cancers,and endocrine disorders.While biologics have proven to be effective in treating or managing many diseases,patient acce-ss is often limited by high costs.The development of biosimilars is an attempt to reduce treatment costs.Biosimilars must be nearly identical to their reference biologics in terms of efficacy,side effect risk profile,and immunogenicity.Although the manufacturing process still involves production within living cells,biosimilars undergo fewer clinical trials than do their reference biologics.This ultimately reduces the cost of production and the cost of the biosimilar drug compared to its reference biologic.Currently,seven biosimilars have been approved by the United States Food and Drug Administration(FDA)for use in Crohn’s disease,ulcerative colitis,and colorectal cancer.There are other biologics involved in treating gastroenterologic diseases for which there are no FDA approved biosimilars.Although biosimilars have the po-tential to reduce healthcare costs in chronic disease management,they face challenges in establishing a sig-nificant market share.Physician comfort in prescribing reference biologics instead of biosimilars and patient reluctance to switch from a biologic to a biosimilar are two common contributing factors to biosimilars’slow in-crease in use.More time will be needed for biosimilars to establish a larger and more consistent market share compared to their reference biologics.Additional da-ta confirming the safety and efficacy of biosimilars,increased number of available biosimilars,and further cost reduction of biosimilars will all be necessary to im-prove physician confidence in biosimilars and patient comfort with biosimilars.展开更多
Cancer is a major public health issue worldwide, especially in the developing world where 70% of the cancer-related deaths occur. During the last three decades, with the advent of targeted therapies using monoclonal a...Cancer is a major public health issue worldwide, especially in the developing world where 70% of the cancer-related deaths occur. During the last three decades, with the advent of targeted therapies using monoclonal antibodies, patients’ survival and quality of life have dramatically improved. Unfortunately, these great accomplishments came at the expense of high financial costs which most of the population living in low-and middle-income countries cannot afford. Biosimilars (biotherapeutic products that are similar to an already licensed reference biotherapeutic product in terms of quality, safety and efficacy) have been successfully used in Europe and in US with a substantial reduction in price of around 30%. Brazil is about to have trastuzumab as the first biosimilar available to treat cancer patients in the country. Based on strict regulatory legislations, biosimilars are expected to deliver affordable yet effective and safe treatment options all over the world, expanding the access to cancer treatment and reducing inequalities.展开更多
The introduction of biological treatments has changed disease outcomes for patients with inflammatory bowel disease. Biologicals have high efficacy, and can induce and maintain remission after failed responses to conv...The introduction of biological treatments has changed disease outcomes for patients with inflammatory bowel disease. Biologicals have high efficacy, and can induce and maintain remission after failed responses to conventional immunosuppressive and/or steroid therapy. The increasing occurrence of severe disease at diagnosis has resulted in infliximab being more often introduced as the firstline treatment in a "top-down" approach. Besides their favourable efficacy and safety profile, biologicals have one significant disadvantage, which is their high cost. This results in many patients stopping therapy prematurely, with the maintenance phase being too short. This often leads to disease exacerbation shortly after treatment cessation. Every newly started course of biological therapy can induce production of anti-drug antibodies, which can result in treatment failure and possible allergic/anaphylactic reactions. The introduction of biological biosimilars was intended to greatly reduce therapy costs thus increasing the availability of these agents to more patients. It was also anticipated that biosimilars would prevent premature termination of therapy. Analyses of paediatric data suggest that biosimilar infliximabs are equally effective as the reference infliximab. Safety patterns also seem to be similar. Paediatric experience places costtherapy reductions at around 10%-30%.展开更多
BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases(IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab ...BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases(IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with IBD.METHODS An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar(CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the biosimilar.RESULTS98 patients(CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar(P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar(P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar. CONCLUSION The overall efficacy and loss of treatment response with infliximab biosimilar(CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.展开更多
Many biologic products have improved the outcomes of cancer patients,but the costs can substantially burden healthcare systems.Biosimilar products can potentially reduce drug costs and increase patient access to benef...Many biologic products have improved the outcomes of cancer patients,but the costs can substantially burden healthcare systems.Biosimilar products can potentially reduce drug costs and increase patient access to beneficial treatments.Approval of a biosimilar product relies on the demonstration of "comparability" or "no clinically meaningful differences" as compared to its reference biologic product.Biosimilar products for erythropoietin,granulocyte colonystimulating factor,trastuzumab,and rituximab are already available,and the regulatory processes in various countries are constantly evolving.It is important that oncologists be familiar with the potential issues surrounding the clinical use of biosimilar products.In this review article,we provide background information about biosimilar products and their regulatory approval processes,followed by a discussion of individual biosimilar drugs.展开更多
In this article we discuss the challenges of delivering a high quality Transition care. A good understanding of the adolescent needs with good communication between Transition care physicians and the patient is essent...In this article we discuss the challenges of delivering a high quality Transition care. A good understanding of the adolescent needs with good communication between Transition care physicians and the patient is essential for good continuity of care. Despite availability of several guidelines, one model doesn't fit all and any transition service development should be determined by the local need and available healthcare facilities.展开更多
Diabetes mellitus, an endocrine disorder, has a wider reach among most of the world population. The incidence of diabetes is high not only among adults but wider-age groups are also becoming susceptible to this diseas...Diabetes mellitus, an endocrine disorder, has a wider reach among most of the world population. The incidence of diabetes is high not only among adults but wider-age groups are also becoming susceptible to this disease because of modified food habits and lifestyle changes that are alien to the physiological system. The control of blood glucose level would be the prime focus of all the therapeutic targets, which is achieved through drugs, modified lifestyle, and paleo-based diets. To find a solution to these problems, earlier humans have revolutionized the science with the discovery of insulin from the porcine pancreatic crude extract. Later, developments have been made with artificial recombinant insulin and even insulin analogs that would mimic the physiological basal insulin in controlling the blood sugar levels. Various factors such as cost and logistics for quality delivery to the end-user at various corners of the world have impeded the reach of the original product. Hence, biosimilar insulins that are original insulin analogs were designed to execute similar physiological functions. In the current situation, the use of biosimilars has been approved in various clinical conditions that are very promising in its functions. In the present review, the various developmental phases of biosimilar preparations and the regulations enforced ensuring a quality product in the market through the Food and Drug Administration and the European Medicines Agency have been discussed.展开更多
The increasing incidence of inflammatory bowel disease(IBD)globally has redirected the healthcare system's focus towards safe and affordable pharmacological interventions.The inception of anti-tumor necrosis fact...The increasing incidence of inflammatory bowel disease(IBD)globally has redirected the healthcare system's focus towards safe and affordable pharmacological interventions.The inception of anti-tumor necrosis factor-α(TNF-α)had resulted in a trend shift from surgical interventions.However,as the patents of approved anti-TNF-αdrugs expire,biological copies of the many approved products are in the pipeline.The most commonly used biosimilar for IBD has been infliximab,followed by Adalimumab biosimilars which have been approved in major countries across the world.Although biosimilars are approved on the basis of similarity of their reference product,the lack of real-world evidence of its safety in ulcerative colitis and Crohn’s disease patients has contributed to physicians’hesitancy.However,biosimilars are expected to reduce treatment costs and provide economic benefits.展开更多
BACKGROUND In recent years,biological therapies have revolutionized the management of inflammatory bowel disease(IBD);however,they are expensive.The development of biosimilar products has allowed us to reduce healthca...BACKGROUND In recent years,biological therapies have revolutionized the management of inflammatory bowel disease(IBD);however,they are expensive.The development of biosimilar products has allowed us to reduce healthcare costs and improve patients’access to these treatments.Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety,there are unmet needs regarding research on these agents in the context of IBD.AIM To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice.METHODS An observational,prospective,multicenter study of IBD patients treated with CTP13 in clinical practice who were naïve to biological treatments or failed to respond to other anti-tumor necrosis factor drugs or had switched from infliximab originator was carried out.No diagnostic or follow-up interventions were conducted on patients outside usual clinical practice.The primary endpoints were clinical response rates and number of adverse events.The primary efficacy variable was the proportion of patients who were in clinical remission and/or had a clinical response at 3,6,9,and 12 mo.RESULTS A total of 220 IBD patients treated with CT-P13(Remsima®)were included in the study:87(40%)with ulcerative colitis and 133(60%)with Crohn’s disease.Mean age of the patients was 41.47(SD 15.74)years,and 58%were female.Nineteen(9%)patients started treatment with CT-P13 after switching from infliximab.Of the remaining 201 patients,142(65%)were naïve to biologic agents.At baseline,68.6%(n=138/201)of patients presented with active disease.After 12 mo of treatment,14.8%(n=12/81)presented with active disease,and 64.2%(n=52/81)were in clinical remission without corticosteroids.After 3 mo,75.5%(n=115/152)had a clinical response or achieved clinical remission,which was sustained for 12 mo(85.2%;n=69/81).There was a decrease in specific IBD indices at 3,6,9,and 12 mo(P<0.001).A total of 34 adverse events were reported by 27(12.3%)patients,9(26.5%)of which were serious.CONCLUSION CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD in real-life practice and may be a valid and attractive alternative for the treatment of IBD.展开更多
Objective: Present Phase IV Trial is aimed at evaluating the immunogenicity, safety, and efficacy of Wockhardt’s insulin glargine, Glaritus®in comparison with reference insulin glargine, Lantus®in sub...Objective: Present Phase IV Trial is aimed at evaluating the immunogenicity, safety, and efficacy of Wockhardt’s insulin glargine, Glaritus®in comparison with reference insulin glargine, Lantus®in subjects with type 2 diabetes mellitus (T2DM), inadequately controlled on oral hypoglycaemics. Setting: A head-to-head, prospective, open-label, parallel group, randomized, Phase IV, non-inferiority study over 6 months treatment conducted in 10 centres in India. Participants: Considering 20% drop-out rate, 180 subjects of either sex, age 18 - 55 years, diagnosed with T2DM with body mass index (BMI) 18 - 38 kg/m2 and HbA1c levels 8.0% - 10.0% inadequately controlled by 1 or more oral hypoglycaemics and according to investigator needed glargine treatment were enrolled in the study. Interventions: Subjects self-administered insulin glargine (Glaritus®or Lantus®) subcutaneously once daily for 6 months. Treatment in Glaritus®arm was continued till 12 months. Percentage change in anti-insulin antibody (AIA) titre and HbA1C was ascertained at every 3 months interval. The tests were performed at accredited central laboratory. Treat-to-target dose titration: Starting doses of Glaritus®and Lantus®was 10 units (or 0.2 units/kg) once daily. The target fasting blood glucose was 70 to 130 mg/dL. Daily glargine dose was titrated by ±10% based on average of last 3 FBG values being out of target range and presence of nocturnal hypoglycemia. Early data trends: First interim analysis was planned once 100 subjects complete visit 8 (6 months treatment). By then, 119 subjects (78 males and 41 females) with mean age 46.3 years were enrolled, of which 90 (75.6%) subjects had evaluable data. The results of analysis indicated trend of comparability between Glaritus®and Lantus®at the end of 6 months in terms of immunogenicity (% change in AIA titre from baseline, −10.52 ± 23.06 vs. 0.48 ± 63.95), glycemic control (change in HbA1c from baseline, −1.09% ± 1.29% vs. 0.63% ± 1.19%) and hypoglycemic events (reported by 1 vs. 2 patients), respectively. Conclusion: The present study represents a robust design in line with international guidelines on biosimilar insulin development and the early data trends presents expected similarity of Glaritus®in immunogenicity, efficacy and safety to that of Lantus®in treatment of T2DM.展开更多
A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica ge...A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica gel 60 F254s HPTLC plates, as stationary phase. The mobile phase optimized for Filgrastim and Etanercept was Water: n-butanol (7.5:2.5 v/v) and Isopropyl alcohol: water (6.5:4.5 v/v), respectively. The chromatogram obtained was scanned at 225 nm and 222 nm for filgrastim and etanercept which resulted in a retention factor of 0.45 ± 0.07 and 0.32 ± 0.03, respectively. The method was validated for parameters like linearity, accuracy, precision, specificity and robustness. Recovery studies were performed at three concentration levels, to demonstrate suitability, accuracy and precision of proposed method. Statistical analysis proved that the proposed method is accurate and reproducible with linearity in the range of 500 to 3000 ng/band for filgrastim and 200 to 1200 ng/band for etanercept. The limit of detection and limit of quantification for filgrastim was found to be 63.418 ng/band and 192.177 ng/band. For etanercept, LOD and LOQ were found to be 33.381 ng/band and 101.153 ng/band, respectively. The proposed method can be employed for the routine analysis of selected biosimilars.展开更多
BACKGROUND There is a lack of studies and educational programs focused on biosimilars and shared decision-making among patients diagnosed with various rheumatic diseases.AIM To improve knowledge and awareness of biosi...BACKGROUND There is a lack of studies and educational programs focused on biosimilars and shared decision-making among patients diagnosed with various rheumatic diseases.AIM To improve knowledge and awareness of biosimilars and shared decision-making among patients attending rheumatology practices in Colorado as well as to assess a rheumatology patient’s interest in discussing biosimilars as well as shared decision-making with others(e.g.,medical professionals,family members,friends).METHODS Our goal was to work with 80 rheumatology teams in Colorado.We developed and distributed 2000 multi-page brochures to each participating office and later conducted an online anonymous survey.RESULTS There were a total of 49(2.5%)rheumatology patients who responded to our survey.After reading our educational booklet,many survey respondents identified the correct answer in most questions focused on biosimilars or shared decision-making.Our survey results suggest that patients attending rheumatology practices in Colorado are generally not involved in discussions with their providers regarding treatment plans or options.The improvement in scores after reading our educational materials was statistically significant for biosimilars and shared decision-making.CONCLUSION Overall,the level of knowledge and awareness of biosimilars and shared decisionmaking among patients attending rheumatology practices in Colorado was low.More educational programs as well as follow up trainings to measure changes in knowledge and awareness regarding biosimilars and shared decision-making among patients attending rheumatology practices are recommended.展开更多
Aim： EPO （erythropoietin） is a hormone that stimulates the erythropoiesis and is mainly produced by the kidneys. In the early 1990s among the emerging biotech drugs, the recombinant human EPO （rhEPO） was the best...Aim： EPO （erythropoietin） is a hormone that stimulates the erythropoiesis and is mainly produced by the kidneys. In the early 1990s among the emerging biotech drugs, the recombinant human EPO （rhEPO） was the best-selling product worldwide, reaching nearly three billion dollars annually. The CIM （center of molecular immunology） produced and sold the rhEPO as commercial strategy to recover the investment made in its new facilities. This work summarizes the inventions that protect the innovative products developed by three Cuban institutions, starting from rhEPO, and the industrial property strategy followed by them. Methods： The information was obtained from the United States Patent, Trademark Office （USPTO） database, Patentscope, Espacenet, patent databases of Center for Pharmaceutical Research and Drug Development （CIDEM） and Cuban Industrial Property Office. Conclusions： The manufacturing process of CIM＇s EPO has its own patent family. From a manufacturing by product an innovative formulation protected by patent was obtained. There is a patent family around the nasal formulation and it continues enlarging. From a biosimilar pharmaceutical innovative products impacting on human health have been obtained.展开更多
文摘Objective To put forward some suggestions for improving the registration and regulation,the efficiency of evaluation,and approval of biosimilar in China so as to promote the development of biopharmaceutical industry and increase the accessibility of therapeutic drugs in China.Methods Literature related to the registration and regulation,evaluation and approval of biosimilars were sorted out to analyze the differences in China and the USA.Results and Conclusion Based on the analysis of the current situation of registration and regulation of biosimilars between China and the USA,it is suggested to improve the registration and regulation of biosimilars in China from the following four aspects:Establishing a biosimilar regulatory department,expanding the professional evaluation personnel,scientifically simplifying the registration and approval procedures,and constantly refining the types of communication meetings.
文摘A biologic drug is a medication produced from or containing components of living organisms.Given the rigorous testing that originator biologics undergo to establish Food and Drug Administration(FDA)Biologics License Application(BLA)approval,their subsequent price yields a high burden on healthcare systems(1).Biologics account for 37%of prescription drug spending,despite comprising only 2%of all prescribed medications(2).Biosimilar medicines are designed to have active properties that are“highly similar”to a previously licensed reference product,leading to increased chemistry,manufacturing,and controls(CMC).
文摘BACKGROUND Over the last decade,the treatment options for inflammatory bowel disease(IBD)have significantly progressed with the emergence of new medications designed to target various immune pathways and mitigate inflammation.Adalimumab(ADA)is a tumor necrosis factor alpha antagonist and stands as an effective treatment for IBD.In April 2021,the province of British Columbia implemented a mandatory non-medical switch policy of the ADA originator Humira®to ADA biosimilars.Biosimilars offer a potential cost-effective,safe,and efficacious alternative to the originator,yet there remains limited real-world evidence on long-term outcomes of ADA non-medical switching in IBD.AIM To assess the long-term outcomes of non-medical switching from the ADA originator Humira®to an ADA biosimilar among IBD patients.METHODS A retrospective observational chart review study was conducted on IBD patients eligible for the provincially mandated non-medical switch to an ADA biosimilar.The primary outcome was treatment persistence at 30 months post-switch.Secondary outcomes included the proportion of and reasons for therapy alteration or ADA discontinuation,loss of response(LOR)rates,adverse events(AE),and clinical and biochemical remission status.Patients who remained on the originator throughout the switch period,through compassionate support or private pay,constituted the comparison group.RESULTS Patients in the originator(n=43)and biosimilar switch(n=228)groups displayed similar demographics and baseline disease characteristics.By the study endpoint of 30 months,there was no difference in the rate of treatment persistence in either group(n=36,83.7%originator group vs n=201,88.2%biosimilar group,P=0.451).Treatment persistence demonstrated similar rates of discontinuation between both study groups(log-rank P=0.543).There was a numerical but not statistically significant difference in rates of adverse outcomes between either group(39.5%originator vs 28.9%biosimilars,P=0.206).This included comparable rates of LOR(27.9%vs 17.5%)or AE(11.6%vs 11.4%)between the originator and biosimilar cohorts,respectively.C-reactive protein and fecal calprotectin levels were similar one year pre-and post-switch.CONCLUSION These data support the long-term efficacy and safety of non-medical ADA switching in IBD and will help inform patients and physicians in jurisdictions currently undergoing biosimilar switching.
基金Supported by Ministry of Science and Higher Education of the Russian Federation,No.075-15-2022-301the Russian Science Foundation Grant,No.22-45-08004.
文摘BACKGROUND Juvenile systemic lupus erythematosus(SLE)is a severe,life-threatening disease.However,the role of rituximab in managing juvenile SLE remains undefined,although early biological intervention may improve disease outcomes.AIM To assess the differences in the outcomes of different types of rituximab administration(early and late).METHODS In this retrospective cohort study,the information of 36 children with SLE with administration(LRA)was analyzed.We compared initial disease characteristics at onset,at baseline(start of rituximab),and at the end of the study(EOS)at 12 months,as well as outcomes and treatment characteristics.RESULTS The main differences at baseline were a higher daily median dose of corticosteroids,increased MAS frequency,and a higher Systemic Lupus Erythematosus Disease Activity Index(SLEDAI)in the ERA group.No differences in the main SLE outcomes between groups at the EOS were observed.The part of lupus nephritis patients who achieved remission changed from 44%to 31%in ERA and 32%to 11%in the LRA group.Patients with ERA had a shorter time to achieve low daily corticosteroid dose(≤0.2 mg/kg)at 1.2(0.9;1.4)years compared to 2.8(2.3;4.0)years(P=0.000001)and higher probability to achieve this low dose[hazard ratio(HR)=57.8(95%confidence interval(CI):7.2-463.2),P=0.00001 and remission(SLEDAI=0);HR=37.6(95%CI:4.45-333.3),P=0.00001].No differences in adverse events,including severe adverse events,were observed.CONCLUSION ERA demonstrated a better steroid-sparing effect and a possibility of earlier remission or low disease activity,except for lupus nephritis.Further investigations are required.
文摘Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods. A similar biologic drug, commonly called biosimilar, is a product copied by a native approved biologic drug whose license has expired. Biosimilar drugs usually are marketed at a lower price and provide important financial savings for public healthcare systems. Some differences between biosimilars and original biologic drugs might exist but they are acceptable if they fall within defined “boundaries of tolerance”: differences in some features between the two molecules are considered important only if clinical relevant. Considering that the efficacy of the innovator biologic drug has already been established, the clinical studies required for approval of a biosimilar could be reduced compared with those required for the approval of the originator. In this review, real life data available in inflammatory bowel disease patients treated with biosimilars are reported, documenting in general satisfactory outcomes, sustained efficacy and no sign of increased immunogenicity, although, further controlled data are awaited.
基金funded by Shanghai Henlius Biotech, Inc., Science and Technology Commission of Shanghai Municipality (No. 14431908500)China National Major Project for New Drug Innovation (No. 2012ZX09303012)。
文摘Objective: This study aimed to compare the pharmacokinetic, pharmacodynamic and safety profiles of HLX01(a rituximab biosimilar) and reference rituximab sourced from China(Mab Thera?;rituximab-CN).Methods: Here we report the results of two phase 1 studies. In the phase 1 a, open-label, dose-escalation study(NCT03218072, CTR20140400), eligible patients received 250, 375 and 500 mg/m^(2) HLX01 sequentially at 7-day intervals, after confirming no dose-limiting toxicity(DLT). In the phase 1 b, double-blind study(NCT02584920,CTR20140764), eligible patients were given a single dose of 375 mg/m^(2) HLX01 or rituximab-CN. The primary endpoints included safety and tolerability parameters for the phase 1 a and the area under the plasma concentrationtime curve from time zero to day 91(AUC0-91 d) for the phase 1 b study. Equivalence was concluded if 90%confidence interval(90% CI) for the geometric least squares mean ratio(GLSMR) fell in the pre-specified equivalence criteria(80%-125%).Results: Between June 20, 2014 and January 5, 2015, 12 patients were enrolled in the phase 1 a study. The pharmacokinetics of HLX01 showed dose proportionality and accumulation to steady state. HLX01 was well tolerated, with no serious adverse events(AEs), discontinuations or DLTs. Between November 8, 2014 and August13, 2015, 87 eligible patients were enrolled in the phase 1 b study, including 43 who received HLX01 and 44 who were treated with rituximab-CN. The equivalence endpoint was met with GLSMR for AUC0-91 d being 89.6%(90% CI: 80.4%-99.8%). AEs, anti-drug antibodies, and CD19+ and CD20+ B lymphocyte counts were similar between the HLX01 and rituximab-CN treatment groups.Conclusions: Treatment with HLX01 was safe and well tolerated in Chinese patients with B-cell lymphoma.HLX01 and rituximab-CN have similar pharmacokinetic, pharmacodynamic and safety profiles.
文摘Biologic therapy, such as those that target tumor necrosis factor(TNF) signaling, has proven to be an efficacious method of treatment for patients with inflammatory bowel disease(IBD) with regards to symptom management and mucosal healing. However, the rising prevalence of IBD worldwide and the everincreasing burden of biologic pharmaceuticals in the health care industry is alarming for insurance companies, clinicians, and patients. The impending patent expiry and the relatively high costs of biologics, particularly anti-TNF agents, have paved the way for biosimilar development for IBD. The United States Food and Drug Administration defines a biosimilar as a biological product that is highly similar to its reference medicinal product, with no clinically meaningful differences in terms of safety, purity, and potency. The hope with biosimilars is that their entry into the market will be able to drive competition between pharmaceutical companies to reduce prices like that of the generic market, and that access to appropriate biologic treatments for IBD patients is increased in the long-term. Yet, there are challenging issues such as indication extrapolation and interchangeability that are still being debated in the field of IBD and must be addressed in future issued guidance. This review will discuss the issues and implications concerning the use of biosimilar therapy for IBD.
文摘Biosimilars are a growing drug class designed to be used interchangeably with biologics.Biologics are cr-eated in living cells and are typically large,complex pr-oteins that may have a variety of uses.Within the field of gastroenterology alone,biologics are used to treat inflammatory bowel diseases,cancers,and endocrine disorders.While biologics have proven to be effective in treating or managing many diseases,patient acce-ss is often limited by high costs.The development of biosimilars is an attempt to reduce treatment costs.Biosimilars must be nearly identical to their reference biologics in terms of efficacy,side effect risk profile,and immunogenicity.Although the manufacturing process still involves production within living cells,biosimilars undergo fewer clinical trials than do their reference biologics.This ultimately reduces the cost of production and the cost of the biosimilar drug compared to its reference biologic.Currently,seven biosimilars have been approved by the United States Food and Drug Administration(FDA)for use in Crohn’s disease,ulcerative colitis,and colorectal cancer.There are other biologics involved in treating gastroenterologic diseases for which there are no FDA approved biosimilars.Although biosimilars have the po-tential to reduce healthcare costs in chronic disease management,they face challenges in establishing a sig-nificant market share.Physician comfort in prescribing reference biologics instead of biosimilars and patient reluctance to switch from a biologic to a biosimilar are two common contributing factors to biosimilars’slow in-crease in use.More time will be needed for biosimilars to establish a larger and more consistent market share compared to their reference biologics.Additional da-ta confirming the safety and efficacy of biosimilars,increased number of available biosimilars,and further cost reduction of biosimilars will all be necessary to im-prove physician confidence in biosimilars and patient comfort with biosimilars.
文摘Cancer is a major public health issue worldwide, especially in the developing world where 70% of the cancer-related deaths occur. During the last three decades, with the advent of targeted therapies using monoclonal antibodies, patients’ survival and quality of life have dramatically improved. Unfortunately, these great accomplishments came at the expense of high financial costs which most of the population living in low-and middle-income countries cannot afford. Biosimilars (biotherapeutic products that are similar to an already licensed reference biotherapeutic product in terms of quality, safety and efficacy) have been successfully used in Europe and in US with a substantial reduction in price of around 30%. Brazil is about to have trastuzumab as the first biosimilar available to treat cancer patients in the country. Based on strict regulatory legislations, biosimilars are expected to deliver affordable yet effective and safe treatment options all over the world, expanding the access to cancer treatment and reducing inequalities.
文摘The introduction of biological treatments has changed disease outcomes for patients with inflammatory bowel disease. Biologicals have high efficacy, and can induce and maintain remission after failed responses to conventional immunosuppressive and/or steroid therapy. The increasing occurrence of severe disease at diagnosis has resulted in infliximab being more often introduced as the firstline treatment in a "top-down" approach. Besides their favourable efficacy and safety profile, biologicals have one significant disadvantage, which is their high cost. This results in many patients stopping therapy prematurely, with the maintenance phase being too short. This often leads to disease exacerbation shortly after treatment cessation. Every newly started course of biological therapy can induce production of anti-drug antibodies, which can result in treatment failure and possible allergic/anaphylactic reactions. The introduction of biological biosimilars was intended to greatly reduce therapy costs thus increasing the availability of these agents to more patients. It was also anticipated that biosimilars would prevent premature termination of therapy. Analyses of paediatric data suggest that biosimilar infliximabs are equally effective as the reference infliximab. Safety patterns also seem to be similar. Paediatric experience places costtherapy reductions at around 10%-30%.
文摘BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases(IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with IBD.METHODS An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar(CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the biosimilar.RESULTS98 patients(CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar(P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar(P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar. CONCLUSION The overall efficacy and loss of treatment response with infliximab biosimilar(CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.
文摘Many biologic products have improved the outcomes of cancer patients,but the costs can substantially burden healthcare systems.Biosimilar products can potentially reduce drug costs and increase patient access to beneficial treatments.Approval of a biosimilar product relies on the demonstration of "comparability" or "no clinically meaningful differences" as compared to its reference biologic product.Biosimilar products for erythropoietin,granulocyte colonystimulating factor,trastuzumab,and rituximab are already available,and the regulatory processes in various countries are constantly evolving.It is important that oncologists be familiar with the potential issues surrounding the clinical use of biosimilar products.In this review article,we provide background information about biosimilar products and their regulatory approval processes,followed by a discussion of individual biosimilar drugs.
文摘In this article we discuss the challenges of delivering a high quality Transition care. A good understanding of the adolescent needs with good communication between Transition care physicians and the patient is essential for good continuity of care. Despite availability of several guidelines, one model doesn't fit all and any transition service development should be determined by the local need and available healthcare facilities.
基金supported by the KU Research Professor Program of Konkuk UniversitySeoulSouth Korea
文摘Diabetes mellitus, an endocrine disorder, has a wider reach among most of the world population. The incidence of diabetes is high not only among adults but wider-age groups are also becoming susceptible to this disease because of modified food habits and lifestyle changes that are alien to the physiological system. The control of blood glucose level would be the prime focus of all the therapeutic targets, which is achieved through drugs, modified lifestyle, and paleo-based diets. To find a solution to these problems, earlier humans have revolutionized the science with the discovery of insulin from the porcine pancreatic crude extract. Later, developments have been made with artificial recombinant insulin and even insulin analogs that would mimic the physiological basal insulin in controlling the blood sugar levels. Various factors such as cost and logistics for quality delivery to the end-user at various corners of the world have impeded the reach of the original product. Hence, biosimilar insulins that are original insulin analogs were designed to execute similar physiological functions. In the current situation, the use of biosimilars has been approved in various clinical conditions that are very promising in its functions. In the present review, the various developmental phases of biosimilar preparations and the regulations enforced ensuring a quality product in the market through the Food and Drug Administration and the European Medicines Agency have been discussed.
文摘The increasing incidence of inflammatory bowel disease(IBD)globally has redirected the healthcare system's focus towards safe and affordable pharmacological interventions.The inception of anti-tumor necrosis factor-α(TNF-α)had resulted in a trend shift from surgical interventions.However,as the patents of approved anti-TNF-αdrugs expire,biological copies of the many approved products are in the pipeline.The most commonly used biosimilar for IBD has been infliximab,followed by Adalimumab biosimilars which have been approved in major countries across the world.Although biosimilars are approved on the basis of similarity of their reference product,the lack of real-world evidence of its safety in ulcerative colitis and Crohn’s disease patients has contributed to physicians’hesitancy.However,biosimilars are expected to reduce treatment costs and provide economic benefits.
文摘BACKGROUND In recent years,biological therapies have revolutionized the management of inflammatory bowel disease(IBD);however,they are expensive.The development of biosimilar products has allowed us to reduce healthcare costs and improve patients’access to these treatments.Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety,there are unmet needs regarding research on these agents in the context of IBD.AIM To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice.METHODS An observational,prospective,multicenter study of IBD patients treated with CTP13 in clinical practice who were naïve to biological treatments or failed to respond to other anti-tumor necrosis factor drugs or had switched from infliximab originator was carried out.No diagnostic or follow-up interventions were conducted on patients outside usual clinical practice.The primary endpoints were clinical response rates and number of adverse events.The primary efficacy variable was the proportion of patients who were in clinical remission and/or had a clinical response at 3,6,9,and 12 mo.RESULTS A total of 220 IBD patients treated with CT-P13(Remsima®)were included in the study:87(40%)with ulcerative colitis and 133(60%)with Crohn’s disease.Mean age of the patients was 41.47(SD 15.74)years,and 58%were female.Nineteen(9%)patients started treatment with CT-P13 after switching from infliximab.Of the remaining 201 patients,142(65%)were naïve to biologic agents.At baseline,68.6%(n=138/201)of patients presented with active disease.After 12 mo of treatment,14.8%(n=12/81)presented with active disease,and 64.2%(n=52/81)were in clinical remission without corticosteroids.After 3 mo,75.5%(n=115/152)had a clinical response or achieved clinical remission,which was sustained for 12 mo(85.2%;n=69/81).There was a decrease in specific IBD indices at 3,6,9,and 12 mo(P<0.001).A total of 34 adverse events were reported by 27(12.3%)patients,9(26.5%)of which were serious.CONCLUSION CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD in real-life practice and may be a valid and attractive alternative for the treatment of IBD.
文摘Objective: Present Phase IV Trial is aimed at evaluating the immunogenicity, safety, and efficacy of Wockhardt’s insulin glargine, Glaritus®in comparison with reference insulin glargine, Lantus®in subjects with type 2 diabetes mellitus (T2DM), inadequately controlled on oral hypoglycaemics. Setting: A head-to-head, prospective, open-label, parallel group, randomized, Phase IV, non-inferiority study over 6 months treatment conducted in 10 centres in India. Participants: Considering 20% drop-out rate, 180 subjects of either sex, age 18 - 55 years, diagnosed with T2DM with body mass index (BMI) 18 - 38 kg/m2 and HbA1c levels 8.0% - 10.0% inadequately controlled by 1 or more oral hypoglycaemics and according to investigator needed glargine treatment were enrolled in the study. Interventions: Subjects self-administered insulin glargine (Glaritus®or Lantus®) subcutaneously once daily for 6 months. Treatment in Glaritus®arm was continued till 12 months. Percentage change in anti-insulin antibody (AIA) titre and HbA1C was ascertained at every 3 months interval. The tests were performed at accredited central laboratory. Treat-to-target dose titration: Starting doses of Glaritus®and Lantus®was 10 units (or 0.2 units/kg) once daily. The target fasting blood glucose was 70 to 130 mg/dL. Daily glargine dose was titrated by ±10% based on average of last 3 FBG values being out of target range and presence of nocturnal hypoglycemia. Early data trends: First interim analysis was planned once 100 subjects complete visit 8 (6 months treatment). By then, 119 subjects (78 males and 41 females) with mean age 46.3 years were enrolled, of which 90 (75.6%) subjects had evaluable data. The results of analysis indicated trend of comparability between Glaritus®and Lantus®at the end of 6 months in terms of immunogenicity (% change in AIA titre from baseline, −10.52 ± 23.06 vs. 0.48 ± 63.95), glycemic control (change in HbA1c from baseline, −1.09% ± 1.29% vs. 0.63% ± 1.19%) and hypoglycemic events (reported by 1 vs. 2 patients), respectively. Conclusion: The present study represents a robust design in line with international guidelines on biosimilar insulin development and the early data trends presents expected similarity of Glaritus®in immunogenicity, efficacy and safety to that of Lantus®in treatment of T2DM.
文摘A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica gel 60 F254s HPTLC plates, as stationary phase. The mobile phase optimized for Filgrastim and Etanercept was Water: n-butanol (7.5:2.5 v/v) and Isopropyl alcohol: water (6.5:4.5 v/v), respectively. The chromatogram obtained was scanned at 225 nm and 222 nm for filgrastim and etanercept which resulted in a retention factor of 0.45 ± 0.07 and 0.32 ± 0.03, respectively. The method was validated for parameters like linearity, accuracy, precision, specificity and robustness. Recovery studies were performed at three concentration levels, to demonstrate suitability, accuracy and precision of proposed method. Statistical analysis proved that the proposed method is accurate and reproducible with linearity in the range of 500 to 3000 ng/band for filgrastim and 200 to 1200 ng/band for etanercept. The limit of detection and limit of quantification for filgrastim was found to be 63.418 ng/band and 192.177 ng/band. For etanercept, LOD and LOQ were found to be 33.381 ng/band and 101.153 ng/band, respectively. The proposed method can be employed for the routine analysis of selected biosimilars.
文摘BACKGROUND There is a lack of studies and educational programs focused on biosimilars and shared decision-making among patients diagnosed with various rheumatic diseases.AIM To improve knowledge and awareness of biosimilars and shared decision-making among patients attending rheumatology practices in Colorado as well as to assess a rheumatology patient’s interest in discussing biosimilars as well as shared decision-making with others(e.g.,medical professionals,family members,friends).METHODS Our goal was to work with 80 rheumatology teams in Colorado.We developed and distributed 2000 multi-page brochures to each participating office and later conducted an online anonymous survey.RESULTS There were a total of 49(2.5%)rheumatology patients who responded to our survey.After reading our educational booklet,many survey respondents identified the correct answer in most questions focused on biosimilars or shared decision-making.Our survey results suggest that patients attending rheumatology practices in Colorado are generally not involved in discussions with their providers regarding treatment plans or options.The improvement in scores after reading our educational materials was statistically significant for biosimilars and shared decision-making.CONCLUSION Overall,the level of knowledge and awareness of biosimilars and shared decisionmaking among patients attending rheumatology practices in Colorado was low.More educational programs as well as follow up trainings to measure changes in knowledge and awareness regarding biosimilars and shared decision-making among patients attending rheumatology practices are recommended.
文摘Aim： EPO （erythropoietin） is a hormone that stimulates the erythropoiesis and is mainly produced by the kidneys. In the early 1990s among the emerging biotech drugs, the recombinant human EPO （rhEPO） was the best-selling product worldwide, reaching nearly three billion dollars annually. The CIM （center of molecular immunology） produced and sold the rhEPO as commercial strategy to recover the investment made in its new facilities. This work summarizes the inventions that protect the innovative products developed by three Cuban institutions, starting from rhEPO, and the industrial property strategy followed by them. Methods： The information was obtained from the United States Patent, Trademark Office （USPTO） database, Patentscope, Espacenet, patent databases of Center for Pharmaceutical Research and Drug Development （CIDEM） and Cuban Industrial Property Office. Conclusions： The manufacturing process of CIM＇s EPO has its own patent family. From a manufacturing by product an innovative formulation protected by patent was obtained. There is a patent family around the nasal formulation and it continues enlarging. From a biosimilar pharmaceutical innovative products impacting on human health have been obtained.
