国际生物类似药研发审批和监管的进展

Advances in approval and supervision of the similar biotherapeutic product

"生物类似药"(biosimilar)这一术语指的是生物制品的后续产品,与原研药之间有极高的相似性或可比性,通常生物类似药被批准用于与原研药相同的适应症。因为原研药的治疗费用高昂,使得应用受限,不能满足医疗需求。使用生物类似药不仅可降低治疗费用,也便于推广。虽然美国食品药物管理局(FDA)最早提出规范监管可比性的观念,但是欧洲药监局(EMA)首先将其应用于生物类似药,现在美国FDA(2012)也为生物类似药出台了指南草案,以规范审批流程。值得关注的是,从现在开始,现有的复杂生物制品,尤其是单克隆抗体的专利逐渐到期,使这些重要的原研药的生物类似药正处于全球制药行业药物研发的前列。这些将获得批准的新生物类似药对促进患者治疗和获得高品质的生物药物至关重要。

Due to the high cost of treatment and quality of biological products, the clinical application for that biosimilars is limited, so they can not meet the medical needs of our country and the world. ＂ Biosimilar＂ （ similar biotherapeutic products, SBPs） , a term refers to the success of biological medicine development, has high comparability or similarity with the original biologic product, thus usually is approved for the same indications with the original drugs. Use of biogenetic drugs has reduced the cost of treatment in many parts of the world, and now a standard way for the approval of these products has established in the United States. The U.S. Food and Drug Administration （FDA） first proposed the concept of regulation of comparability and supervision, and the European Medicine Administration （EMA） first applied it for biosimilar drugs. Patents of the complex biological products have begun to expire, in particular monoclonal antibody, so these biologically important drugs and generic drugs are being researched and developed. The FDA issued three draft guidance documents in 2012 that describe how the biosimilar approval process will work. FDA approval of biosimilar drugs will promote access to quality and affordable society truly innovative drug molecules, these new molecules are in the midst of the global biopharmaceutical industry R＆D pipeline.