Press Releases

American College of Rheumatology Responds to FDA Draft Guidance on Biosimilar Interchangeability

Rheumatologists express support for robust switching studies; clear labeling, dispensing, and naming guidelines; increased resources for FDA operations

Statement from Sharad Lakhanpal, MBBS, MD, President of the American College of Rheumatology:

“Today, the American College of Rheumatology submitted comments to the U.S. Food and Drug Administration concerning the draft guidance, ‘Considerations in Demonstrating Interchangeability with a Reference Product’ (FDA 2017-01042).’ We commend the FDA for striking an appropriate balance between ensuring the safety and efficacy of these drugs while also bringing biosimilar products to market as efficiently as possible.

The introduction of additional FDA-approved biosimilars to the U.S. healthcare system is vital to slow the progression of rheumatic disease, improve treatment outcomes, and lower drug prices for patients. However, we must also ensure that patients continue to receive drugs that are safe, effective, and consistent with their healthcare provider’s treatment plan.

To that end, we strongly support the FDA’s proposal to require manufacturers to use robust switching studies to determine whether alternating between a biosimilar and its reference product impacts the safety or efficacy of the drug. Such studies are vital to achieve a clear understanding of what patients are likely to experience with changing formularies in a multi-payer, multi-state, and ever-changing market. These data should be open and accessible for outside investigators to analyze, and should be made clearly available to prescribing doctors in the interchangeable drug’s label via text or hyperlink. Further, we urge the FDA to consider requiring manufacturers to submit updated and standardized pharmacovigilance data as a prerequisite to certain post-market labeling changes.

While the ACR does not support automatic extrapolation, we do believe that extrapolation should be rigorously studied and fully utilized to help reduce the cost of these drugs. Throughout the biosimilar approval process, care must be taken to ensure that a drug pursuing interchangeability has successfully demonstrated extrapolation for all indications for which the originator is approved.

We also reiterate our support for FDA’s stated plan to use distinguishing suffixes to minimize the inadvertent or inappropriate substitution of biosimilars that have not been determined to be interchangeable. In addition, the ACR supports using meaningful suffixes to improve clinical care and pharmacovigilance. We firmly believe that individual treatment decisions should be made by physicians and patients who are fully informed about the unique conditions and circumstances of an individual patient. Therefore, we support clear labeling and dispensing guidance to ensure that a drug’s status of interchangeability is visible to both doctor and patient. The ACR recommends that each biosimilar FDA label indicate whether a drug is interchangeable, that clinical data for biosimilars be included on FDA labels, and that specific guidance be adopted to prevent the inadvertent substitution of a non-interchangeable biosimilar.

Finally, it is imperative that the FDA have the necessary resources to continue its important work on biosimilars. To that end, the Biosimilar User Fee Act II should be passed as soon as possible and the FDA should be granted specific budget authority to quickly onboard experts, issue industry guidance, and review and approve new drugs. Biopharmaceuticals remain expensive not only because they are complex, but also because competition is limited and the markets are opaque. Supporting the FDA’s work at this crucial juncture will introduce competition to the marketplace, help to reduce the cost of these drugs, and ensure our patients continue to receive safe and effective treatments.”

Jocelyn Givens
404-633-3777, ext. 810
jgivens@rheumatology.org

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The American College of Rheumatology (ACR) is the nation's leading advocacy organization for the rheumatology care community, representing more than 9,500 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.

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