Simoens Steven, Lockhart Catherine M, Courmier Delphine F
KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.
AMCP Biologics and Biosimilars Collective Intelligence Consortium, Alexandria, VA, United States.
Front Pharmacol. 2025 Feb 24;16:1538866. doi: 10.3389/fphar.2025.1538866. eCollection 2025.
Experience with the use of biosimilars in real-life practice provides an excellent opportunity to collect real-world evidence aimed at addressing residual uncertainties about biosimilars. Hence, this aims to explore the role of real-world evidence on biosimilars by showcasing how real-world evidence studies have contributed to addressing key questions affecting biosimilar market access. We find that the comparable efficacy and safety of a biosimilar and the reference product is corroborated by real-world evidence. Also, real-world evidence has been used to validate the regulatory approach of extrapolation of indication, to examine the impact of switching practices and policy measures affecting the uptake of biosimilars, to illustrate the benefits of biosimilars, and to identify operational aspects affecting the use of biosimilars in daily practice. We also argue that real-world evidence can serve to demonstrate biosimilar interchangeability in the United States. These cases confirm that real-world evidence can be a powerful tool to elucidate aspects of biosimilar market access outside the context of a randomised controlled trial.
在实际临床实践中使用生物类似药的经验，为收集真实世界证据提供了绝佳机会，这些证据旨在解决有关生物类似药尚存的不确定性。因此，本文旨在通过展示真实世界证据研究如何有助于解决影响生物类似药市场准入的关键问题，来探讨真实世界证据在生物类似药方面的作用。我们发现，真实世界证据证实了生物类似药与参比产品具有相当的疗效和安全性。此外，真实世界证据已被用于验证适应症外推的监管方法，研究换药行为及政策措施对生物类似药使用的影响，阐明生物类似药的益处，以及识别影响生物类似药日常使用的操作层面问题。我们还认为，真实世界证据可用于在美国证明生物类似药的可互换性。这些案例证实，在随机对照试验之外，真实世界证据可以成为阐明生物类似药市场准入相关问题的有力工具。
