Jeske Walter, Walenga Jeanine M, Hoppensteadt Debra, Fareed Jawed
Cardiovascular Institute.
Drug Healthc Patient Saf. 2013 Jun 10;5:133-41. doi: 10.2147/DHPS.S28813. Print 2013.
Generic forms of chemically-derived drugs must exhibit chemical identity and be bioequivalent in healthy human subjects. The use of generic drugs results in a considerable savings of healthcare expenditures. Biologic drugs are produced in living systems or are derived from biologic material and extend beyond proteins to include antibodies, polysaccharides, polynucleotides, and live viral material. Such drugs pose a challenge to characterize as they tend to be larger in size than chemically-derived drugs, can exhibit a variety of post-translational modifications, and can have activities that are dependent on specific conformations. Biosimilars are not true generics, but rather, exhibit a high degree of similarity to the reference product and are considered to be biologically and clinically comparable to the innovator product. Therefore, the development process for biosimilars is more complex than for a true generic. Guidance is now available from the US Food and Drug Administration and from the European Medicines Agency for the development of biosimilar drugs. Biosimilar drugs are expected to have a major impact in the management of various diseases in coming years.
化学合成药物的仿制药必须具有化学一致性，并且在健康人体受试者中具有生物等效性。使用仿制药可大幅节省医疗保健支出。生物药物是在生物系统中生产的，或源自生物材料，其范围不仅包括蛋白质，还包括抗体、多糖、多核苷酸和活病毒材料。这类药物的特性鉴定颇具挑战，因为它们往往比化学合成药物更大，可能呈现多种翻译后修饰，并且其活性可能依赖于特定构象。生物类似药并非真正的仿制药，而是与参比产品具有高度相似性，并被认为在生物学和临床上与创新产品具有可比性。因此，生物类似药的研发过程比真正的仿制药更为复杂。美国食品药品监督管理局和欧洲药品管理局现已发布了关于生物类似药研发的指南。预计生物类似药在未来几年对各种疾病的治疗将产生重大影响。
