Kos Igor Age, Azevedo Valderílio Feijó, Neto Daniel Egg, Kowalski Sérgio Cândido
Federal University of Paraná, Curitiba, Paraná, Brazil.
Edumed, Educação em Saúde, Curitiba, Paraná, Brazil.
Drugs Context. 2018 Oct 1;7:212543. doi: 10.7573/dic.212543. eCollection 2018.
Biosimilar products are already approved and marketed in several countries. The Food and Drug Administration has approved ten different biosimilars, and the European Medicines Agency has approved 40. Even though this scenario has provided important experience with biosimilar products, there are still challenges and unanswered questions. Up to now, a good amount of knowledge has been gathered in order to support the importance of the totality of evidence and the construction of a biosimilarity exercise for regulatory approval. In addition, the extrapolation of indications has been proved viable when a careful analysis is performed. The models for clinical trials and the use of the most sensible populations have been extensively discussed, and there is apparent homogeneity in manufacturer choices for study designs. However, some challenges remain. The lack of regulatory harmony, especially concerning naming, the marketed intended copies, the interchangeability, and the biosimilars in orphan diseases are some of those and are the focus of discussion in this review.
生物类似药产品已在多个国家获得批准并上市。美国食品药品监督管理局已批准了十种不同的生物类似药，欧洲药品管理局则批准了40种。尽管这种情况为生物类似药产品积累了重要经验，但仍存在挑战和未解决的问题。到目前为止，已经积累了大量知识，以支持证据总体的重要性以及构建用于监管批准的生物相似性评估。此外，当进行仔细分析时，适应症的外推已被证明是可行的。临床试验模型和最敏感人群的使用已得到广泛讨论，并且在研究设计的制造商选择方面存在明显的同质性。然而，一些挑战仍然存在。监管缺乏协调性，特别是在命名、上市的预期仿制品、可互换性以及罕见病生物类似药方面，这些是其中的一些问题，也是本综述讨论的重点。
