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Biosimilar swapping wins favor in FDA budget

Mar 12, 2024
Illustration of a vial with price tags on it showing the cents symbol.

Illustration: Aïda Amer/Axios

Senate efforts to make biosimilars more easily interchangeable with the products they copy got a boost in President Biden's FY25 budget, when the FDA endorsed automatic swapping as part of a package of legislative proposals to boost competition.

Why it matters: The idea was part of a primary care-health workforce package that Senate HELP Chair Bernie Sanders sponsored, as well as stand-alone legislation that backers argue is needed as drug development moves toward more expensive biological products.

The FDA said separate standards now required to prove interchangeability have led to confusion and misunderstanding, and that the policy change would be "more consistent with current scientific understanding."

  • It also would bring the U.S. in line with regulations in places like Europe, where biosimilars are deemed interchangeable upon approval.

Flashback: The Affordable Care Act envisioned expanded use of generic versions of complex biological products. But, as we've noted, adoption has been slow due to regulatory red tape and market incentives favoring brand-name treatments.

What's next: The move to scrap a biosimilar interchangeability standard is among a series of legislative reforms the FDA showcased during Monday's budget rollout under the heading "Facilitating Competition."

  • Others include amending the three-year period of exclusivity that new drugs can qualify for that FDA said can delay generic competition, and creating a "skinny label" safe harbor from patent infringement liability for makers of human and animal generic drugs.
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