The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. Specifically, the U.S. Department of Health & Human Services (HHS)’s 2025 proposed budget includes a budget-neutral provision for allowing biosimilar substitution without a separate determination of interchangeability. According to HHS, “[t]he statutory distinction between biosimilars and interchangeable biosimilars has led to confusion and misunderstanding, including among patients and healthcare providers, about the safety and effectiveness of biosimilars and about whether interchangeable biosimilars are safer or more effective than other biosimilars.”
HHS proposes to “amend section 351 of the Public Health Service Act to no longer include a separate statutory standard for a determination of interchangeability and to deem all approved biosimilars to be interchangeable with their respective reference products.” According to HHS, “[t]his change makes the U.S. biosimilar program more consistent with current scientific understanding as well as with the approach adopted by other major regulatory jurisdictions such as the European Union where biosimilars are interchangeable with their respective reference products upon approval,” and “is expected to increase uptake of safe and affordable biosimilars, with potential downstream effects of increasing competition, and access.”
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