Division of Pulmonary, Allergy, and Rheumatology Products, Office of New Drugs, HFD-570, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
Division of Biotechnology Review and Research 1, Office of Biotechnology Products, HFD-123, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
Nat Rev Rheumatol. 2017 Feb;13(2):123-128. doi: 10.1038/nrrheum.2016.204. Epub 2017 Jan 5.
Biologic products have revolutionized the management of many rheumatic diseases, but access to these products might be limited by their relatively high costs. The US Biologics Price Competition and Innovation Act of 2009, which is contained within the Patient Protection and Affordable Care Act, established an abbreviated pathway for licensure by the FDA of biologic products that are demonstrated to be biosimilar to or interchangeable with FDA-licensed biologic products, termed reference products. This law allows for the approval of biosimilar biologic products, which are expected to increase access to treatment for patients, and ensuring the implementation of this Act is a high priority for the FDA. In this Perspectives article we describe the considerations for approval of proposed biosimilar products, including those to treat rheumatological conditions, by describing the FDA's rigorous approach to assessment of biosimilarity.
生物制品已经彻底改变了许多风湿性疾病的治疗方法，但由于其相对较高的成本，这些产品的应用可能会受到限制。美国 2009 年《生物制品价格竞争与创新法案》包含在《患者保护与平价医疗法案》中，为美国食品和药物管理局（FDA）批准生物类似药建立了一个简化途径，这些生物类似药被证明与 FDA 批准的生物制品（称为参比产品）具有生物相似性或可互换性。该法律允许批准生物类似药，预计这将增加患者获得治疗的机会，并确保该法案的实施是 FDA 的首要任务。在这篇观点文章中，我们通过描述 FDA 对生物相似性评估的严格方法，描述了用于治疗风湿性疾病的拟议生物类似药产品的批准考虑因素。
