The Biden Administration proposes to amend s352 of the Public Health Service Act so that all approved biosimilars are deemed to be interchangeable with their respective reference drug.
On 11 March 2024, the Biden Administration released its 2025 Budget Proposal in which it recommends allowing biosimilar substitution without FDA’s determination of interchangeability. According to U.S. Department of Health & Human Services (HHS):
“The 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”