ACR praises FDA plan to end switching study requirement for interchangeable biosimilars
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Key takeaways:
- The ACR commended an FDA proposal that interchangeable biosimilars no longer require switching studies.
- ACR also cautioned against substituting biosimilars without prescriber, patient knowledge.
The American College of Rheumatology has applauded an FDA proposal to streamline the approval of interchangeable biosimilars, removing requirements for switching studies to determine their interchangeability with reference products.
In a comment letter submitted to the FDA, the ACR also cautioned the agency to protect patient prescriptions from being switched to biosimilars due to insurance and pharmacy benefit manager mandates.
So far, the FDA has required that proposed interchangeable biosimilars undergo switching studies, in which a biosimilar is alternated with its reference product to assess the safety and efficacy of switching. However, FDA researchers have reported no adverse safety outcomes associated with switching, and new analytical tools are more precise and sensitive than switching studies, according to the draft guidance published by the FDA on June 20.
“The FDA, in abrogating the requirement for switching studies, has removed the only significant barrier to interchangeability,” ACR President Deborah Dyett Desir, MD, wrote in the full ACR comment letter. “Rather than conducting studies, applicants can use modeling to support interchangeability, drastically decreasing the investment necessary to obtain approval of a biosimilar as interchangeable.
“While we emphasize the need for continued scientific rigor to protect patient safety, the ACR supports the FDA’s lowering of this standard because it would increase access to interchangeable drug products,” she added.
However, the ACR also expressed concern regarding another part of the guidance, which stated an interchangeable biosimilar may be substituted for the reference product without the intervention of the prescribing physician.
“We are very concerned about, and opposed to, mandates from health insurers and pharmacy benefit managers to switch from originator products to biosimilars,” Desir wrote. “All pharmacy-level switching must be fully transparent. The prescribing provider and the patient should be informed in a timely manner when a switch at the pharmacy counter occurs.”
References:
ACR comment letter to FDA. https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/blt1beaaa3f4e28ff65/advocacy-letter-fda-interchangeability-guidance-comments.pdf. Published Aug. 20, 2024. Accessed Aug. 26, 2024.
FDA updates guidance on interchangeability. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-guidance-interchangeability. Published June 20, 2024. Accessed Aug. 26, 2024.
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