Rathore Anurag S, Stevenson James G, Chhabra Hemlata, Maharana Chinmoyee
Department of Chemical Engineering, Indian Institute of Technology, Delhi, India.
Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, USA.
Expert Opin Biol Ther. 2022 Feb;22(2):133-148. doi: 10.1080/14712598.2021.1889511. Epub 2021 May 6.
Biosimilars hold the potential to be an integral healthcare component that can significantly improve affordability and thereby accessibility of the otherwise expensive biotherapeutic products. Regulators, payors, and policymakers, each have a major role to play in successful adoption of biosimilars. One of the issues that has been a point of frequent discussion is that of interchangeability of biosimilars.
This article aims to review the position that the major regulatory bodies have taken on interchangeability of biosimilars. Key issues that remain are also discussed. Adalimumab and etanercept have been chosen as real-world case studies to demonstrate interchangeability considerations. The need for gaining global harmonization on interchangeability is highlighted.
A global harmonization on the interchangeability can likely accelerate biosimilar adoption and result in better accessibility to biologics. Experience gained with real-world studies supports switching to biosimilars from originators however post-marketing pharmacovigilance should be in place to assess the risk-benefit profile of biosimilars in the long run.
生物类似药有可能成为医疗保健的一个重要组成部分，可显著提高可承受性，从而使原本昂贵的生物治疗产品更易获得。监管机构、支付方和政策制定者在生物类似药的成功采用中都发挥着重要作用。生物类似药的可互换性一直是频繁讨论的问题之一。
本文旨在回顾主要监管机构对生物类似药可互换性的立场。还讨论了仍然存在的关键问题。已选择阿达木单抗和依那西普作为实际案例研究，以说明可互换性考量。强调了在可互换性方面实现全球协调统一的必要性。
在可互换性方面实现全球协调统一可能会加速生物类似药的采用，并使生物制品更易获得。实际研究获得的经验支持从原研药转向生物类似药，不过从长远来看，应开展上市后药物警戒，以评估生物类似药的风险效益情况。
