Tufts Center for the Study of Drug Development, Boston, MA, USA.
MAbs. 2009 Sep-Oct;1(5):394-416. doi: 10.4161/mabs.1.5.9630. Epub 2009 Sep 25.
The European Medicines Agency (EMEA) workshop on biosimilar monoclonal antibodies (mAbs), held July 2, 2009 at the EMEA headquarters in London, was a harbinger with potentially far-reaching implications for all groups interested in antibody therapeutics development. These groups include not only regulators and the innovator and generic biopharmaceutical industries, but also physicians, patients and payers. The objective of the workshop was to discuss and assess the feasibility of the development and authorization of mAbs using EMEA's biosimilar regulatory pathways. The workshop sequentially focused on questions relevant to three areas: (1) chemistry, manufacturing and controls (CMC), (2) non-clinical issues and (3) clinical issues, including outcome measures. Proceedings of the workshop are presented in Part 1 of this report, and discussed within the context of the legal, regulatory and business environments of the European Union, Asia and the United States in Parts 2, 3 and 4, respectively.
欧洲药品管理局（EMEA）于 2009 年 7 月 2 日在其位于伦敦的总部举办了一场关于生物类似药单克隆抗体（mAb）的研讨会，这预示着所有对抗体治疗药物开发感兴趣的团体都可能受到深远的影响。这些团体不仅包括监管机构、创新药和仿制药生物制药行业，还包括医生、患者和支付方。研讨会的目的是讨论和评估使用 EMEA 的生物类似药监管途径开发和授权 mAb 的可行性。该研讨会依次侧重于与三个领域相关的问题：（1）化学、制造和控制（CMC），（2）非临床问题，（3）临床问题，包括结局指标。研讨会的记录在本报告的第 1 部分中呈现，并在第 2、3 和 4 部分中分别结合欧盟、亚洲和美国的法律、监管和商业环境进行了讨论。
