Biosimilar Red Tape Elimination Act

This bill, titled the Biosimilar Red Tape Elimination Act, aims to change how the U.S. regulates and determines that a biological product (a biosimilar) is interchangeable with its reference product. It restructures Section 351(k) of the Public Health Service Act to streamline or even automatically deem interchangeability under certain conditions, creates a transition date 60 days after enactment, and preserves existing first-interchangeable exclusivity for products that already had it. It also reduces or reconfigures certain language and references across related statutes and requires the Department of Health and Human Services (HHS) to update and issue guidance within 18 months. Overall, the bill seeks to reduce regulatory “red tape” and accelerate the availability and substitutability of biosimilars, while maintaining some protections tied to exclusivity for products that had an earlier exclusivity period.