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

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.