A May 28, 2024 review article by Skylar Jeremias titled, “New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching” (here), supports the fact that switching between biologics and biosimilars or from one biosimilar to another does not present a problem. The article states “[S]ince the July 2022 publication of the first systematic review of biosimilar-to-biosimilar switching, the European Medicines Agency and the European Heads of Medicines Agencies have issued statements supporting the safety and efficacy of such switching. The U.S. FDA’s systematic review and meta-analysis also found no safety or immunogenicity differences between patients who switched biosimilars and those who did not.”
The author does note “there remains skepticism globally about the safety of switching between biosimilars, particularly in gastroenterology and ophthalmology spaces.” This type of skepticism remains in the generic space as well for several classes of narrow therapeutic range small molecule drugs among certain physician specialties; however, even for these drugs, the Office of Generic Drugs maintains that all generics can be expected to have the same therapeutic effect and safety profile to their brand name counterparts. Although the FDA says the same about biosimilars, the fact that the FDA has a separate designation of interchangeable for certain biosimilars continues to cause confusion.
The article outlines findings from some of the clinical studies, observational studies, and articles in its review of biosimilar switching and its impact on patients.
