Department of Hospital Pharmacy and Internal Medicine, Erasmus Medical Center, CA, Rotterdam, The Netherlands.
Transpl Int. 2013 Aug;26(8):771-7. doi: 10.1111/tri.12074. Epub 2013 Feb 27.
Within the field of solid organ transplantation, the patents for a number of immunosuppressive drugs have expired in the last few years. Tacrolimus, cyclosporine, and mycophenolate mofetil are now available as generic drugs. In some countries, the market penetration of these generic formulations is as high as 70%, whereas in some other countries, this figure is below 10%. Several professional societies have published position papers on the risks and benefits of generic substitution of immunosuppressive drugs. It often appears that transplant professionals are not fully aware of the requirements for registration of generic drugs. This article describes the registration requirements with a focus on bioequivalence testing, the strengths and weaknesses in this process, and the differences between Europe and the US.
在实体器官移植领域，过去几年中已有多种免疫抑制剂药物的专利过期。他克莫司、环孢素和霉酚酸酯现在都可以作为仿制药使用。在一些国家，这些仿制药的市场渗透率高达 70%，而在另一些国家，这一数字则低于 10%。一些专业协会已经发布了关于免疫抑制剂药物仿制药替代的风险和益处的立场文件。看起来，移植专业人员并没有完全了解仿制药注册的要求。本文描述了注册要求，重点介绍了生物等效性测试，该过程的优缺点，以及欧洲和美国之间的差异。
