The following is from Dr. Angus Worthing, Chair of the American College of Rheumatology’s Government Affairs Committee:
“The American College of Rheumatology (ACR) applauds the FDA final guidance, “Considerations in Demonstrating Interchangeability with a Reference Product,” which establishes an approval pathway for interchangeable biosimilars and balances biosimilar uptake and provider confidence concerns while prioritizing the safety of our patients.
Specifically, we are pleased to see that the final guidance expects manufacturers to use robust switching studies. At least three switches with each switch crossing over to the alternate product will be needed to determine whether alternating between a biosimilar and its reference product impacts the safety or efficacy of the drug. The ACR believes these studies will provide an understanding of what patients are likely to experience when changing formularies in a multi-payer, multi-state market.
We are also pleased to see the FDA finalize its approach to safety, immunogenicity, and efficacy for the demonstration of interchangeability. And we agree with the FDA that post-marketing safety monitoring for an interchangeable product should also have robust pharmacovigilance mechanisms in place. In order to improve clarity, the ACR suggests that FDA prescribing information for all biosimilars include statements about whether each agent is or is not interchangeable to the reference product.
The ACR shares the FDA’s goal of ensuring that more affordable treatments reach patients as quickly as possible and appreciates the agency’s measured and thoughtful approach throughout this process.”