On July 22, 2026, the U.S. Senate Committee on Health, Education, Labor and Pensions (“HELP”) voted to advance the Expedited Access to Biosimilars Act (S. 1414). The Senate action followed the introduction of a House version of the bill (H. R. 9661) and consideration of the bill by the House Committee on Energy and Commerce earlier in July.

The bill would amend Section 351(k) of the Public Health Service Act to codify that comparative efficacy and PD studies are not automatically required for biosimilar licensure while preserving the FDA’s authority to require such studies when warranted. The bill also requires that the FDA provide early written notice to the sponsor if additional studies are deemed necessary.  The stated purpose of the bill is to reduce the cost of biosimilar development.

The House Committee on Energy and Commerce also reintroduced the Biosimilar Red Tape Elimination Act (H. R. 5526), following the Senate HELP Committee’s advancement of the Senate version (S. 2305) in June 2026 (previously reported Senate HELP Committee Advances Bills Addressing FDA / USPTO Disclosures and Biosimilar Interchangeability). The bill would amend Section 351(k) of the Public Health Service Act to deem biosimilars licensed under that subsection interchangeable with their reference products, eliminating the current separate determination by the FDA for interchangeability. The bill includes transition provisions, including a 60-day transition period and preservation of unexpired first interchangeable exclusivity granted before enactment. The bill also would require the FDA to update relevant biosimilar guidance within 18 months after enactment.

These bills follow guidance developments from the FDA addressing the clinical studies generally recommended to support biosimilarity and interchangeability. The FDA’s June 2024 draft guidance stated that applicants may provide an assessment explaining why the comparative analytical and clinical data submitted in the application or supplement support interchangeability, rather than conducting a switching study (previously reported FDA Revises Guidance on Switching Studies for Biosimilar Interchangeability). The Biosimilar Red Tape Elimination Act would go further by eliminating the separate statutory interchangeability determination for biosimilars licensed under Section 351(k).

Separately, on July 21, 2026, S. 5059 (text not yet available) was introduced to amend the Public Health Service Act to streamline review of biosimilar biological products. The bill was referred to the Senate HELP Committee.

The bills have not been enacted and require further congressional action before they become law.

For more information about these and other biosimilars and related regulatory and patent developments, please visit BiologicsHQ.

 

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The authors would like to thank April Breyer Menon for her contributions to this article.