Faculté de Pharmacie, Université Clermont Auvergne, Laboratoire de Biopharmacie, MEDIS, 28 Place H. Dunant, 63001 Clermont-Ferrand, France.
Pharmacokinetics and Generic Medicines, Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Calle Campezo 1-Edificio 8, 28022 Madrid, Spain.
Eur J Pharm Sci. 2018 Jan 1;111:399-408. doi: 10.1016/j.ejps.2017.10.013. Epub 2017 Oct 12.
This review describes the EMA requirements on biowaivers for additional strengths of immediate release and modified release oral solid dosage forms focused on generic applications and highlights the challenges for a simultaneous EMA and FDA submission. Some specificities of the current EMA guidelines are compared with the current FDA Guidance for Industry, with a special focus on the strength to be investigated in vivo, formulation suitability for biowaiver, and optimizing dissolution studies for additional strength biowaivers. In Europe, the same principles applied for generics may be considered for deriving the biowaivers for innovator products. Several case studies are presented to illustrate the challenges of applying for additional strength biowaivers in EMA and FDA simultaneously.
本文综述了 EMA 对即时释放和改良释放口服固体制剂的额外强度的生物豁免的要求，重点关注仿制药申请，并强调了同时向 EMA 和 FDA 提交申请所面临的挑战。本文比较了当前 EMA 指南的一些具体规定与当前 FDA 行业指南，特别关注体内研究的强度、制剂对生物豁免的适用性，以及优化额外强度生物豁免的溶出度研究。在欧洲，对于仿制药而言，同样的原则也可用于推导创新产品的生物豁免。本文通过几个案例研究说明了同时向 EMA 和 FDA 申请额外强度生物豁免所面临的挑战。
