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ACR Issues Statement After FDA Releases Guidance on Biosimilar Interchangeability
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The American College of Rheumatology has issued a statement about the FDA’s draft guidance for biosimilar interchangeability.
“The introduction of additional FDA-approved biosimilars to the U.S. health care system is vital to slow the progression of rheumatic disease, improve treatment outcomes and lower drug prices for patients,” Sharad Lakhanpal, MBBS, MD, president of the American College of Rheumatology (ACR), said. “However, we must also ensure that patients continue to receive drugs that are safe, effective and consistent with their health care provider’s treatment plan.”
Lakhanpal added that switching studies should be more accessible to physicians and that pharmacovigilance data should be required for post-market labeling changes.
“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,” he said. “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.”
Lakhanpal also said the ACR does not support automatic extrapolation, but it should still be studied.
“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,” he said. “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.”
Lakhanpal said suffixes should be distinguished to minimize accidental substitution of biosimilars that have not been deemed interchangeable and should also be meaningful to improve pharmacovigilance and clinical care. In addition, he said the ACR supports clear labelling so interchangeability status can be visible and clinical data can be seen.
The ACR also co-signed a statement by the Biologics Prescribers Collaborative, which recommended that data required for interchangeability should be more extensive than those required for biosimilarity; clinical switching studies should include at least three switches between biosimilar and reference product; and sponsors who attempt to develop presentations for proposed interchangeable products which differ from the reference product should have data demonstrating interchangeability.
“Finally, it is imperative that the FDA have the necessary resources to continue it important work on biosimilars,” Lakhanpal said. “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.”
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