Calvo Begoña, Martinez-Gorostiaga Javier, Echevarria Enrique
Pharmaceutical Technology Department, Faculty of Pharmacy, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz 01008, Spain.
Integrated Healthcare Organisation (OSI Araba), Basque Health Service (Osakidetza), Vitoria-Gasteiz, Spain.
Ther Adv Drug Saf. 2018 Aug 3;9(10):601-608. doi: 10.1177/2042098618790442. eCollection 2018 Oct.
The development of biosimilars is growing rapidly, especially in Europe. They are a cost-effective alternative to original biological medicines and can help improve patient access to these therapies. The European Medicines Agency (EMA) has been the first to issue scientific guidelines related to regulatory requirements for the approval of biosimilars. These guidelines have been being updated in line with advances in analytical techniques and growing experience in the clinical use of these drugs. Given the complex nature of biological medicines, they pose a greater potential risk of immunogenicity than nonbiological medicines, and hence warrant special consideration. The risk management plan for biopharmaceuticals (innovator and biosimilar drugs) should be based on strengthening ongoing pharmacovigilance activities, especially in the post-approval period. This paper addresses regulatory issues related to the approval of biosimilars in Europe associated with safety considerations linked to the development and use of these medicines. We also discuss the issues of immunogenicity, interchangeability and traceability of biological medicines.
生物类似药的发展迅速，尤其是在欧洲。它们是原研生物药具有成本效益的替代选择，有助于改善患者获得这些疗法的机会。欧洲药品管理局（EMA）率先发布了与生物类似药批准监管要求相关的科学指南。这些指南一直在根据分析技术的进步以及这些药物临床使用经验的增加而不断更新。鉴于生物药的复杂性质，它们比非生物药具有更大的免疫原性潜在风险，因此需要特别考虑。生物制药（创新药和生物类似药）的风险管理计划应基于加强持续的药物警戒活动，尤其是在批准后阶段。本文探讨了欧洲与生物类似药批准相关的监管问题，这些问题与这些药物的研发和使用所涉及的安全性考虑有关。我们还讨论了生物药的免疫原性、可互换性和可追溯性问题。
