FDA proposal to remove biosimilar interchangeability status in FY25

Home/Policies & Legislation | Posted 12/06/2024 post-comment0 Post your comment

In a major shift in regulatory policy, the US Food and Drug Administration (FDA) is calling on Congress to remove the interchangeability designation that has historically set biosimilars apart in the US market. Backed by the Biden administration, the FDA's new proposal would permit pharmacy-level substitution of biosimilar drugs for reference products without clinician recommendation. This would extend to all approved biosimilars, regardless of their interchangeability status.

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The FDA’s authority to designate biologicals as interchangeable was created by the Biologics Price Competition and Innovation Act, which came into force in 2010. The proposed plan would remove the current requirement for additional studies and/or clinical trials that can be requested by FDA to designate a biosimilar as interchangeable.  

In fact, on 6 November 2023, the U.S. Centers for Medicare & Medicaid Services (CMS) proposed a new rule that biosimilars can be substituted for the reference biologicals, even if these have not been deemed interchangeable by the FDA [1].

The FDA’s FY25 Legislative Proposals document claims that ‘the statutory distinction between biosimilars and interchangeable biosimilars has led to confusion and misunderstanding […] about the safety and effectiveness of biosimilars and about whether interchangeable biosimilars are safer or more effective than other biosimilars.’ The FY25 proposal would also deem approved biosimilars as interchangeable.

‘The proposal would reduce confusion and increase patient access to lower cost biosimilars. The Biosimilars Council looks forward to working with the administration and Congress to expand patient access to lower cost biosimilars’, said Craig Burton of Biosimilars Council and Association for Accessible Medicines (AAM).

Despite this, Mr Michael S Reilly, Executive Director of the Alliance for Safe Biologic Medicines (ASBM) argues, ‘This move is misguided, as biosimilars differ from generics and require individualized treatment plans. Physician confidence in biosimilars remains high, and the interchangeable standard has effectively built trust. Additionally, biosimilar uptake is influenced by formulary design, not interchangeability. Targeting pharmacy benefit managers practices could better support biosimilar adoption’ [2].

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1. GaBI Online - Generics and Biosimilars Initiative. CMS proposes allowing Part D plans to switch biologicals to non-interchangeable biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 12]. Available from: www.gabionline.net/policies-legislation/cms-proposes-allowing-part-d-plans-to-switch-biologicals-to-non-interchangeable-biosimilars
2. Reilly MS. Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2024;13(2): Epub ahead of print.

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