In a report from Healio, experts described how the introduction of the adalimumab biosimilar adalimumab-adbm (Cyltezo) may have altered the landscape of patient care in rheumatology. With the U.S. Food and Drug Administration’s interchangeable designation issued on July 1, 2023, patients may be treated with adalimumab-adbm in place of adalimumab without additional provider approval. In the randomized phase III VOLTAIRE-X clinical trial (ClinicalTrials.gov identifier NCT03210259), researchers showed that adalimumab-adbm achieved similar pharmacokinetics, efficacy, immunogenicity, and safety compared with adalimumab—supporting its interchangeability with the standard biologic. Although many experts have embraced biosimilars, some experts have voiced concern that switching to a biosimilar from a standard biologic may impact a patient’s treatment experience, introduce new side effects, allow for the return of previous symptoms, increase the overall financial burden of treatment, and lead to a “nocebo” effect. “Recently, we have been able to choose one or another and have had experience with patients going back and forth … and in most cases it does not appear to make a difference,” concluded John R. P. Tesser, MD, FACP, FACR, Adjunct Assistant Professor of Medicine in the Division of Clinical Education at the Arizona College of Osteopathic Medicine at Midwestern University.
July 27, 2023