In the latest episode of the GHAPP & RhAPP Biosimilar Podcast Series, host Gabriella McCarty, NP-C, is joined by Janette Villalon, NP, to discuss the critical topic of interchangeability and switching of biosimilars. As the use of biosimilars continues to expand in gastroenterology and rheumatology, understanding what interchangeability means for providers, pharmacists, and patients is essential.

Janette breaks down the rigorous FDA approval process required for a biosimilar to be designated as interchangeable. Unlike generics, biosimilars are highly complex medications derived from living cells, making them similar—but not identical—to their reference products. Interchangeable biosimilars must undergo additional switch studies to confirm that patients can transition between the reference product and the biosimilar without compromising safety, efficacy, or immunogenicity. While all biosimilars must demonstrate equivalency, only a select few receive official interchangeability status, allowing for pharmacy-level substitution without provider intervention.

The discussion highlights key clinical trials that have shaped biosimilar adoption. The NOR-SWITCH trial played a pivotal role in confirming that patients across multiple disease states, including Crohn’s disease, ulcerative colitis, and rheumatoid arthritis, maintained stable outcomes when switched from the reference biologic to a biosimilar. The VOLTAIRE studies provided further evidence supporting the safety and efficacy of biosimilar switching, particularly with adalimumab.

As biosimilars become increasingly integrated into clinical practice, providers must navigate insurance-driven formulary changes and patient concerns about transitioning from brand-name biologics. While data supports the safety and effectiveness of biosimilar switching, patient education remains key. The conversation emphasizes the importance of transparency, addressing the nocebo effect, and advocating for patients when necessary.

This episode underscores the need for APPs to stay informed about biosimilars, regulatory processes, and the evolving landscape of biologic treatments in gastroenterology and rheumatology. As the market grows, so does the opportunity to expand access to effective, lower-cost therapies for patients

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