Biosimilar Red Tape Elimination Act

This bill changes the requirements for determining when a biosimilar biological product is considered interchangeable with its reference product, effectively deeming most new biosimilars interchangeable upon approval after a transition period. It removes the need for a separate demonstration of interchangeability and updates related legal definitions and guidance.

Sec. 2, Biosimilar biological products: This section amends the Public Health Service Act to remove the separate standard for interchangeability. After a transition date 60 days after enactment, any biosimilar licensed on or after that date is automatically deemed interchangeable, unless another biosimilar relying on the same reference product still has an unexpired first interchangeable exclusivity period from before the bill's enactment, in which case the new biosimilar becomes interchangeable when that exclusivity ends. Biosimilars licensed before the transition date are also deemed interchangeable on that date, subject to the same exclusivity exception. The bill preserves any unexpired first interchangeable exclusivity periods for biosimilars licensed before enactment. It also makes conforming changes to other sections of law to remove references to separate interchangeability standards and updates definitions of biosimilar biological products. The Secretary of Health and Human Services must update guidance within 18 months to reflect these changes, including revising or revoking existing interchangeability guidance documents. The bill clarifies that it does not change the standard or information required for a biosimilar to be licensed as biosimilar to a reference product.