Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Therapeutic Biologics and Biosimilars Staff, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res. 2017 Apr 15;23(8):1882-1885. doi: 10.1158/1078-0432.CCR-16-1354. Epub 2016 Dec 29.
The Biologics Price Competition and Innovation (BPCI) Act, enacted as part of the Affordable Care Act, created a new licensure pathway for biological products demonstrated to be biosimilar with or interchangeable with an FDA-licensed biological product (the "reference product"). The FDA's approach to the regulation of biosimilars is based on the requirements set forth in the BPCI Act. A biosimilar product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between products in terms of safety, purity, and potency. The foundation of a biosimilar development program is an analytic similarity assessment that directly compares the structural/physiochemical and functional properties of the proposed biosimilar with the reference product. Data from clinical studies, which include an assessment of immunogenicity and pharmacokinetics/pharmacodynamics, are used to assess for clinically meaningful differences and not to independently establish the safety and effectiveness of the biosimilar. Like all products that the FDA regulates, the FDA requires that biosimilar products meet the agency's rigorous standards of safety and efficacy for approval. That means patients and health care professionals are able to rely upon the safety and effectiveness of biosimilar products in the same manner as for the reference product. .
生物仿制药竞争与创新法案（BPCI 法案）是《平价医疗法案》的一部分，为与 FDA 批准的生物制品具有生物相似性或可互换性的生物制品（“参照产品”）创建了一种新的许可途径。FDA 对生物类似药的监管方法基于 BPCI 法案中规定的要求。生物类似药与参照产品高度相似，尽管在临床非活性成分方面存在微小差异，但在安全性、纯度和效力方面，产品之间没有临床意义上的差异。生物类似药开发计划的基础是对拟议的生物类似药与参照产品的结构/物理化学和功能特性进行直接比较的分析相似性评估。来自临床研究的数据，包括免疫原性和药代动力学/药效学评估，用于评估是否存在临床意义上的差异，而不是独立确定生物类似药的安全性和有效性。与 FDA 监管的所有产品一样，FDA 要求生物类似药产品达到该机构批准的安全性和有效性的严格标准。这意味着患者和医疗保健专业人员能够以与参照产品相同的方式依赖生物类似药产品的安全性和有效性。
