Department of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo, 71-20133 Milan, Italy.
Department of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo, 71-20133 Milan, Italy.
Drug Discov Today. 2019 Jan;24(1):250-255. doi: 10.1016/j.drudis.2018.08.003. Epub 2018 Aug 4.
The experience gained with biosimilars has made it clear that copies of complex drugs are more challenging to produce and put on the market than generics. In the case of so-called nonbiological complex drugs (NBCDs), the complexity can arise either from a complex active substance or by other factors, such as formulation or route of delivery. Regulatory policies in the USA and the EU for the marketing of NBCD copies are reviewed, using glatiramer acetate copies as a case study. In the USA, they are approved and marketed as generics (although needing additional data), and so they are interchangeable with the originator. In the EU, they are managed with a hybrid application, and their interchangeability and substitution are established by individual member states.
从生物类似药的经验可以清楚地看出，与仿制药相比，复杂药物的仿制更加具有挑战性，也更难推向市场。在所谓的非生物复杂药物（NBCD）的情况下，这种复杂性可能来自于复杂的活性物质，也可能来自于其他因素，例如制剂或给药途径。本文以醋酸格拉替雷（glatiramer acetate）的仿制药为例，综述了美国和欧盟针对 NBCD 仿制药上市的监管政策。在美国，这些仿制药被批准为仿制药（尽管需要额外的数据），因此可以与原研药互换。在欧盟，它们采用混合申请进行管理，其可互换性和可替代性由各个成员国确定。
