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
目的评估在中国获批的5种一线系统治疗方案用于不可切除肝细胞癌的整体效益风险,为临床决策提供参考。方法采用R4.2软件对4项临床试验进行网状Meta分析,间接比较得出5种治疗方案的效应值。结合效益风险指标,应用多准则决策分析模型建立...目的评估在中国获批的5种一线系统治疗方案用于不可切除肝细胞癌的整体效益风险,为临床决策提供参考。方法采用R4.2软件对4项临床试验进行网状Meta分析,间接比较得出5种治疗方案的效应值。结合效益风险指标,应用多准则决策分析模型建立价值树。应用Hiview 3.2软件计算5种治疗方案用于不可切除肝细胞癌的效益值、风险值以及效益风险值,并进行敏感性分析评价结果的稳健性。借助Oracle Crystal Ball软件运行蒙特卡洛模拟,计算5种治疗方案两两比较的效益风险差值、95%可信区间以及出现差异的概率。结果阿替利珠单抗与贝伐珠单抗(AB)、信迪利单抗与贝伐珠单抗生物类似物(SB)、多纳非尼(DN)、仑伐替尼(LF)、索拉非尼(SL)用于不可切除肝细胞癌的效益值分别是35、59、14、25、0;风险值分别是55、40、59、39、50;效益风险值分别是45、50、37、32、25。敏感性分析表明结果较稳健。蒙特卡洛模拟优化模型结果显示,5种治疗方案之间效益风险差有确定差异的是:AB vs SL,SB vs SL和DN vs SL。结论在当前权重下,SB方案可使患者获益最大,为最优治疗方案,其次是AB、DN、LF和SL。临床医师可综合评估患者个体特征及风险耐受度制定决策方案。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
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
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.
文摘目的评估在中国获批的5种一线系统治疗方案用于不可切除肝细胞癌的整体效益风险,为临床决策提供参考。方法采用R4.2软件对4项临床试验进行网状Meta分析,间接比较得出5种治疗方案的效应值。结合效益风险指标,应用多准则决策分析模型建立价值树。应用Hiview 3.2软件计算5种治疗方案用于不可切除肝细胞癌的效益值、风险值以及效益风险值,并进行敏感性分析评价结果的稳健性。借助Oracle Crystal Ball软件运行蒙特卡洛模拟,计算5种治疗方案两两比较的效益风险差值、95%可信区间以及出现差异的概率。结果阿替利珠单抗与贝伐珠单抗(AB)、信迪利单抗与贝伐珠单抗生物类似物(SB)、多纳非尼(DN)、仑伐替尼(LF)、索拉非尼(SL)用于不可切除肝细胞癌的效益值分别是35、59、14、25、0;风险值分别是55、40、59、39、50;效益风险值分别是45、50、37、32、25。敏感性分析表明结果较稳健。蒙特卡洛模拟优化模型结果显示,5种治疗方案之间效益风险差有确定差异的是:AB vs SL,SB vs SL和DN vs SL。结论在当前权重下,SB方案可使患者获益最大,为最优治疗方案,其次是AB、DN、LF和SL。临床医师可综合评估患者个体特征及风险耐受度制定决策方案。
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.
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.
