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
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).
