ACR Statement On FDA Biosimilar Interchangeability Draft Guidance

Rheumatology Leaders Believe FDA Draft Guidance on Biosimilar Interchangeability is a Balanced Approached

The Food and Drug Administration (FDA) has released a draft guidance on biosimilar interchangeability titled “Considerations in Demonstrating Interchangeability With a Reference Product” that leaders at the American College of Rheumatology (ACR) believe may address many of the safety and efficacy concerns physicians have raised over the past year.

“The ACR is pleased to see the FDA issue draft guidance on biosimilar interchangeability,” expressed Dr. Angus Worthing, MD, FACP, chair of the ACR’s Government Affairs Committee. “This guidance brings us one step closer to the shared goal of lowering prices in the biologics marketplace. While the ACR is still reviewing the document and will provide detailed comments to the FDA in the coming weeks, our initial reaction is that the draft guidance strikes a good balance between ensuring safety and efficacy while also getting biosimilar products to market as efficiently as possible.”

“We also applaud the FDA for suggesting clinical studies which switch back and forth, not just one-way from the reference drug to the biosimilar. The use of at least two exposure periods to each drug will mimic to some extent what our patients are likely to experience with changing formularies in a multi-payer, multi-state, ever-changing market."

See the full text of the draft guidance. The ACR plans to submit detailed comments on the guidance in the coming weeks.

About The American College of Rheumatology (ACR)

The American College of Rheumatology (ACR) is the nation’s leading advocacy organization for the rheumatology care community, representing more than 6,400 U.S. rheumatologists and rheumatology health professionals. As an ethically driven, professional membership organization committed to improving healthcare for Americans living with rheumatic diseases, the ACR advocates for high-quality, high-value policies and reforms that will ensure safe, effective, affordable and accessible rheumatology care.