On June 17, 2026, the U.S. Senate Committee on Health, Education, Labor and Pensions (“HELP”) voted to advance the Medication Affordability and Patent Integrity Act and the Biosimilar Red Tape Elimination Act.
The Medication Affordability and Patent Integrity Act would require drug companies to provide certain consistent information to both the FDA and the U.S. Patent and Trademark Office (“USPTO”) in connection with FDA approval and patent protection for a small molecule drug or biologic. The bill requires applicants to certify to the FDA that information submitted is consistent with what was submitted to the USPTO and requires submission to the USPTO any information “material to patentability” that was provided to the FDA. This includes information such as statements or characterizations of analytical data set forth in the chemistry, manufacturing, and controls section of a new drug / biologic license application and statements and characterizations of prior art. It is applicable to all patent claim types, including those covering a drug, formulation, composition, method of use, or method of manufacture. It includes patents issued, assigned, or licensed to the sponsor / holder of the drug / biologic application. To enforce the provisions, the bill would amend Title 35 to include a defense to infringement of applicable drug or biological product patents where the patent owner violates the certification-related requirements by negligently or intentionally failing to disclose required information.
The Biosimilar Red Tape Elimination Act would amend Section 351(k) of the Public Health Service Act to deem biosimilars licensed under that subsection interchangeable with the applicable reference product, eliminating the current separate FDA determination for interchangeability. The bill includes transition provisions, including a 60-day transition period and preservation of unexpired first interchangeable exclusivity granted before enactment. Under those provisions, biosimilars would be deemed interchangeable upon licensure after the transition period, at the end of the transition period for previously licensed biosimilars, or after expiration of an existing first interchangeable exclusivity period, if applicable. The bill would also require the FDA to update relevant biosimilar guidance within 18 months after enactment. If passed, the bill would align U.S. biosimilar policy with global practice, as the U.S. is unique in having separate biosimilar and interchangeable designations.
Earlier versions of the Biosimilar Red Tape Elimination Act have been introduced, beginning in 2022 (previously reported Senator Mike Lee Introduces the Biosimilar Red Tape Elimination Act to Eliminate Switching Study Requirement for Biosimilar Interchangeability), and have consistently moved to simplify biosimilar approval by eliminating the distinction between biosimilars and interchangeables. The FDA has also been moving toward this goal by revising its approach to interchangeability through lessening the need for switching studies (previously reported FDA Revises Guidance on Switching Studies for Biosimilar 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.
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.
