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中国国家食品药品监督管理总局(CFDA)组织药品审评中心(CDE)等技术部门,起草《生物类似药研发与评价技术指导原则(征求意见稿)》(以下简称“征求意见稿”),并于2014年10月29日公开向社会征求意见。尽管本征求意见稿与美国食品药品监督管理局(FDA)于2012年2月9日颁布的指南草案非常相近,但是我们认为本征求意见稿个别条款甚至比FDA的草案更加严谨。例如,CFDA的征求意见稿要求在候选药与参照药之间证明相似性时需考虑批内和批间的相似性。CFDA的征求意见稿甫一出台即吸引了制药企业、生物科技产业、监管机构以及学术界的广泛关注。本文拟对参照药的异质性,非劣效性试验在评估生物等效性中的应用,比例标化的平均生物等效性准则(SABE)的潜在应用,批内和批间变异性在生物等效性评估中的考虑等几项关键问题做一讨论。
China’s State Food and Drug Administration (CFDA) organized the Technical Review Center for Drug Evaluation (CDE) and other technical departments to draft the Guiding Principles for R & D and Evaluation of Biologically Similar Drugs (Draft for Comment) (hereinafter referred to as the “Draft for Exposure”) And publicly solicited opinions from the community on October 29, 2014. Although the ED is very similar to the draft guidance issued by the U.S. Food and Drug Administration on February 9, 2012, we think the individual terms of the ED are even more rigorous than the FDA draft. For example, the CFDA’s Exposure Draft requires the consideration of intra- and inter-lot similarities when demonstrating similarities between drug candidates and reference drugs. The launch of the CFDA’s Exposure Draft attracted widespread attention from pharmaceutical companies, biotech industry, regulators and academia. In this paper, the heterogeneity of reference drugs, the application of noninferiority test in the assessment of bioequivalence, the potential application of proportional normalized bioequivalence criterion (SABE), the intra-assay and inter-assay variability Bioequivalence assessment of several key issues such as a discussion.