Thill Marc
Department of Gynecology and Obstetrics, Agaplesion Markus Hospital, Wilhelm-Epstein-Str 4, 60431 Frankfurt am Main, Germany.
Expert Rev Anticancer Ther. 2015 Mar;15(3):331-8. doi: 10.1586/14737140.2015.993318. Epub 2014 Dec 25.
Trastuzumab is a highly successful monoclonal antibody (mAb) that has been used primarily for the treatment of HER2-positive breast cancer. Because of its success and its impending patent expiry in Europe in 2014, a number of copy versions of trastuzumab have been developed and are currently undergoing a comparability exercise for marketing authorization. Although biosimilar products have been approved in Europe since 2006, including two biosimilar mAbs of infliximab approved in 2013, the use of mAbs such as trastuzumab in the cancer setting has raised a number of new concerns. The requirements for the approval of biosimilar mAbs published by the EMA will be discussed and examined in the context of trastuzumab biosimilars to highlight potential controversies.
曲妥珠单抗是一种非常成功的单克隆抗体（mAb），主要用于治疗HER2阳性乳腺癌。由于其成功以及即将于2014年在欧洲到期的专利，已经开发了多种曲妥珠单抗的仿制品版本，目前正在进行上市许可的可比性研究。尽管自2006年以来欧洲已批准了生物类似药产品，包括2013年批准的两种英夫利昔单抗生物类似单克隆抗体，但在癌症治疗中使用曲妥珠单抗等单克隆抗体引发了一些新问题。将在曲妥珠单抗生物类似药的背景下讨论和审视欧洲药品管理局（EMA）发布的生物类似单克隆抗体批准要求，以突出潜在的争议。
