Biosimilars Forum Announces Support for Bipartisan Interchangeability Legislation

Juliana M. Reed, executive director the Biosimilars Forum, released the following statement announcing support of the bipartisan interchangeability legislation. All biosimilars are fully vetted by the U.S. Food and Drug Administration (FDA) for safety and efficacy. Through this lengthy FDA review process, biosimilars are proven to offer the same clinical benefits and effectiveness as the originator biologic. The full body of research finds no difference in outcome between biosimilars and their reference biologics and between biosimilars to the same reference product.

“The Biosimilars Forum is proud to support the bipartisan legislative proposal addressing interchangeability. Both the U.S. FDA and the European Medicines Agency (EMA) are on record that all biosimilars provide patients with the same clinical experience as their reference products. Based on over a decade of clinical experience and more than five billion patient days of available data, no differences are observed in effectiveness, safety, or immunogenicity for patients starting on biosimilars or being transitioned from a reference product to a biosimilar.

“This bipartisan legislation will allow the FDA to deem a biosimilar interchangeable earlier in the FDA approval process without changing any of robust and stringent scientific requirements for biosimilar approval. 

“All FDA-approved biosimilars undergo a rigorous clinical evaluation so that healthcare providers and patients can be fully confident of the safety, effectiveness, and quality of these products. In fact, the FDA recently released a peer-reviewed scientific paper — Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis — that emphasizes that interchangeability has nothing to do with product safety or effectiveness.

“This FDA paper reiterates that the interchangeability designation has no clinical impact on patients. Interchangeability is NOT a scientific standard. Interchangeability is merely a statutory term that allows for automatic substitution at a retail pharmacy by a pharmacist without authorization of the physician.

“If a patient’s treatment plan includes biosimilars, they can be fully confident that the therapeutic outcome on a biosimilar will be the exact same as the originator biologic — supported by countless FDA reviews, academic studies, and guidelines from healthcare networks and physician societies. This is further supported by the FDA’s systematic review – which uses statistical methods to address the risk of switching patients between reference biologics and biosimilars. This review finds no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or a biosimilar.”

For more information on the Biosimilars Forum’s work to increase access to lower-cost biosimilars, visit biosimilarsforum.org.