Bill > S1954

This bill aims to streamline the process for approving biosimilar biological products (medications similar to but not identical to an original biologic drug) by modifying existing regulations. The bill eliminates the separate determination of interchangeability for biosimilar products, effectively deeming all licensed biosimilar products as automatically interchangeable with their reference products after a 60-day transition period. For biosimilar products already licensed before the bill's enactment, they will be considered interchangeable on the transition date, with some exceptions related to existing exclusivity periods. The legislation also requires the Secretary of Health and Human Services to update existing guidance documents within 18 months, including revising guidelines on demonstrating biosimilar product interchangeability and clarifying the review and approval process for biosimilar applications. Additionally, the bill makes several technical amendments to remove references to interchangeability in various sections of health care legislation, simplifying the regulatory framework for biosimilar biological products and potentially making these alternative medications more accessible to patients.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/1954/all-info