The Expedited Access to Biosimilars Act would amend the Public Health Service Act to change what clinical studies are required for licensure of biosimilar biological products. Under current law, biosimilar applicants may need to provide clinical evidence addressing issues such as immunogenicity, pharmacodynamics, and comparative clinical efficacy. This bill would generally remove any automatic requirement for those assessments in the clinical studies used for biosimilar approval.
Instead, the bill would require clinical studies sufficient to demonstrate safety, purity, and potency, including pharmacokinetic studies and, where appropriate, studies in one or more conditions of use for which the reference product is licensed. The Secretary of Health and Human Services would retain discretion to require immunogenicity, pharmacodynamics, or comparative clinical efficacy testing, but only if the Secretary makes that determination and provides the applicant advance notice with a written justification by the earliest date the application may be filed. The changes would apply only to biosimilar applications submitted on or after enactment.
Impact
The bill would amend section 351(k)(2)(A) of the Public Health Service Act, narrowing the default evidentiary requirements for biosimilar licensure and giving FDA/HHS a more limited, case-by-case role in demanding certain comparative clinical data. Its practical effect would be to potentially reduce development time and cost for biosimilar manufacturers while preserving agency discretion to request additional studies when justified. The bill would affect biosimilar applicants, reference product sponsors, and the FDA’s review process for biological products.
Sentiment
Based on the bill text and the absence of committee debate or recorded votes, the apparent sentiment is supportive of faster biosimilar approval and increased regulatory efficiency. The title and structure of the bill suggest a pro-competition, pro-access approach aimed at lowering barriers for biosimilar entry. No opposing arguments are documented in the provided materials, but the bill’s design implies a policy preference for reducing required clinical testing unless specifically warranted by the Secretary.
Contention
The main point of contention would likely be whether eliminating routine requirements for immunogenicity, pharmacodynamics, and comparative clinical efficacy studies could weaken the evidentiary basis for biosimilar approval. Supporters would likely argue that these studies are often unnecessary and delay market entry, while critics may worry about patient safety, interchangeability concerns, and the adequacy of relying primarily on pharmacokinetic and limited clinical data. Another likely issue is the bill’s shift of discretion to the Secretary, including the requirement for advance written justification, which could be viewed either as a safeguard for applicants or as an administrative constraint on FDA review.
To Mandate The Use Of Biosimilar Medicines Under Health Benefit Plans; To Require A Healthcare Provider To Prescribe Biosimilar Medicines; And To Improve Access To Biosimilar Medicines.
Requires health plan coverage to include generic drugs and biosimilars where the wholesale acquisition cost of such generic drugs or biosimilars is lower than the brand drug's wholesale acquisition cost.