Sandoz Biopharmaceuticals, Sandoz International GmbH, Holzkrichen, Germany.
MAbs. 2011 Mar-Apr;3(2):209-17. doi: 10.4161/mabs.3.2.15005. Epub 2011 Mar 1.
Limited access for high-quality biologics due to cost of treatment constitutes an unmet medical need in the United States (US) and other regions of the world. The term "biosimilar" is used to designate a follow-on biologic that meets extremely high standards for comparability or similarity to the originator biologic drug that is approved for use in the same indications. Use of biosimilar products has already decreased the cost of treatment in many regions of the world, and now a regulatory pathway for approval of these products has been established in the US. The Food and Drug Administration (FDA) led the world with the regulatory concept of comparability, and the European Medicines Agency (EMA) was the first to apply this to biosimilars. Patents on the more complex biologics, especially monoclonal antibodies, are now beginning to expire and biosimilar versions of these important medicines are in development. The new Biologics Price Competition and Innovation Act allows the FDA to approve biosimilars, but it also allows the FDA to lead on the formal designation of interchangeability of biosimilars with their reference products. The FDA's approval of biosimilars is critical to facilitating patient access to high-quality biologic medicines, and will allow society to afford the truly innovative molecules currently in the global biopharmaceutical industry's pipeline.
由于治疗费用高，高质量的生物制剂获得途径有限，这在美国（美国）和世界其他地区构成了未满足的医疗需求。“生物类似药”一词用于指定后续生物制剂，该制剂在与已批准用于相同适应症的原创生物药物的可比性或相似性方面达到极高标准。生物类似药物的使用已经降低了世界许多地区的治疗成本，现在已经在美国建立了这些产品的批准监管途径。美国食品和药物管理局（FDA）率先提出了可比性的监管概念，而欧洲药品管理局（EMA）是第一个将其应用于生物类似药物的机构。现在，针对更复杂的生物制剂（尤其是单克隆抗体）的专利开始到期，这些重要药物的生物类似物版本正在开发中。新的《生物制品价格竞争与创新法案》允许 FDA 批准生物类似物，但也允许 FDA 主导对生物类似物与其参比产品的可互换性进行正式指定。FDA 对生物类似物的批准对于促进患者获得高质量的生物药物至关重要，并且将使社会能够负担得起目前全球生物制药行业产品管线中真正创新的分子。
