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Biosimilar Interchangeability Designation Would Be Nixed Under Biden Proposal

 
• By Derrick Gingery

The proposal is not expected to cost or save the government money, but is expected to increase biosimilar uptake, according to budget documents.

budget
The FDA would receive about $7.2bn in budget authority and user fees in Biden's FY 2025 budget request • Source: Shutterstock

President Biden proposed eliminating the biosimilar interchangeability designation in his fiscal year 2025 budget request, likely a reflection of the push to lower drug prices and the evolving scientific thinking about the products.

Key Takeaways
  • Eliminating the interchangeability distinction would bring the US in line with other major regulators and reflects the current science, Biden administration officials said.
  • Changes to the legal framework are unlikely to happen soon, but FDA is increasingly willing to give biosimilars an interchangeable designation without additional data

Current law states that an approved biosimilar must receive an interchangeability designation before it can be substituted for its reference product without consulting the prescribing physician

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