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PERSPECTIVE article

Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1538866

What role for real-world evidence in market access of biosimilars?

Provisionally accepted
Steven Simoens Steven Simoens 1*Catherine M Lockhart Catherine M Lockhart 2Delphine F Courmier Delphine F Courmier 3
  • 1 KU Leuven, Leuven, Belgium
  • 2 AMCP Biologics and Biosimilars Collective Intelligence Consortium, Alexandria, VA, United States
  • 3 Organon, Jersey City, New Jersey, United States

The final, formatted version of the article will be published soon.

    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 Perspective 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.

    Keywords: Market Access, biosimilar, Real-world evidence, residual uncertainty, Regulatory issues, policy, Benefits, utilisation

    Received: 03 Dec 2024; Accepted: 10 Feb 2025.

    Copyright: © 2025 Simoens, Lockhart and Courmier. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Steven Simoens, KU Leuven, Leuven, Belgium

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.