美国生物类似药的注册审批政策

生物类似药是继原研生物制品之后进入市场,在安全性、纯度和效价上与原研生物制品具有高度相似性的新药物。欧洲药品管理局(EMA)在生物类似物制品注册审批政策的制定中发挥了引领作用,与此同时世界卫生组织(WHO)为促进全球的协调一致也发布了生物类似药审评指导原则。最近,美国食品药品管理局(FDA)依据美国国会2009年通过的"生物制品价格竞争与创新(Biologics Price Competition and Innovation,BPCI)法案"也被授权审批生物类似药。BPCI法案随后于2010年3月23日生效。为了听取民众对于生物类似药注册审批政策的意见,FDA于2010年11月2—3日举行了一场公众听证会。随后,FDA为了生物类似药的审批,成立了生物类似药审查委员会(BRC)专门负责生物类似药开发相关的科学问题,以及注册审批相关指南的制定。FDA于2012年2月9日颁布了3项生物类似药的指导原则草案(科学目的、关键质量指标、以及问题与解答),这些草案的颁布有2个目的:(1)首先,帮助开发商证明仿制生物类似药的生物相似性,并依据公共健康服务(PHS)法案第351(k)款提交上市申请;(2)其次,充分表达FDA在生物类似药开发与注册审批指导原则制定方面的立场。

Biosimilars are a new class of medicine, which enters the market subsequent to the innovator biologic products with demonstrated similarity in safety, purity and potency.The European Medicines Agency(EMA)of European Union(EU)has taken the lead in the regulatory approval framework for biosimilar products, while the World Health Organization(WHO)has also published guidelines on the evaluation of biosimilars in order to facilitate the global harmonization.Recently, the United States(US)Food and Drug Administration(FDA)was authorized to approve follow-on biologics based on the Biologics Price Competition and Innovation(BPCI)Act passed by the US Congress in 2009.The BPCI Act was subsequently enacted on March 23, 2010.To obtain public input for development of regulatory approval pathway, the FDA hosted a Public Hearing on November 2-3, 2010.A Biosimilar Review Committee(BRC)was subsequently formed for identifying scientific factors and development of regulatory approval pathway for assessment of biosimilars.As a result, the FDA circulated three draft guidances(scientific considerations, critical quality attributes, and questions and answers)on February 9, 2012.These draft guidances are(i)to assist sponsors to demonstrate biosimilarity of follow-on biologics for the purpose of submitting a marketing application under section 351(k)of the Public Health Service(PHS)Act, and also(ii)to describe the FDA's current thinking on factors to consider for development of regulatory approval pathway of biosimilars.