Les enjeux de la substitution des biosimilaires comparée à celle des génériques et des hybrides

Abstract

The market of biological drugs is constantly expending, increasing healthcare costs. Facing the expensive cost of the high cost of these drugs, biosimilar drugs have gradually emerged. They are “similar” to the originator drug but less expensive, as they do not have to bear patent and R&D costs. However, these treatments present a high risk of immunogenicity, and are subject to a strict marketing authorization. It also raises the question of their interchangeability, to ensure a high penetration rate. Nevertheless, the mechanism of permutation by the prescriber is well developed. Their substitution by the pharmacist continues to be debated. Legislative and regulatory developments have constantly fluctuated between authorizing substitution and rejecting it. The latest Social Security Financing Act 2024 of December 26th, 2023 should have marked a clear broadening of the conditions for substitution, but the legislator opted for an unambitious solution. These reversals demonstrate the tensions surrounding the issue of biosimilar substitution. On one hand, patients’ fears of any potential adverse effects needs to be acknowledge by healthcare professionals; on the other, the substantial economic stakes involved underline the need to speed up the process. The question of marketing and substituting biosimilar drugs is here addressed in a comparative approach with generic and hybrid drugs. Because biosimilars, like generics and hybrids, are a fantastic opportunity to save funds and reinvest in research, while maintaining the same therapeutic excellence.