Senate Committee Advances Bill to Streamline Biosimilar Approvals
The Senate HELP Committee advanced a bill to streamline biosimilar approvals by relying on analytical tests, potentially cutting development costs and time. The FDA has issued guidance removing comparative efficacy studies and is working to speed post-exclusivity approvals. Combined with administration support and PBM reforms, these moves aim to increase biosimilar competition and reduce drug prices.
The Senate Health, Education, Labor, and Pensions Committee unanimously voted out Sen. Rand Paul’s Expedited Access to Biosimilars Act, which would allow the FDA to approve biosimilars based on analytical tests rather than requiring full clinical trials.
The legislation would permanently codify earlier FDA guidance, enabling faster and less expensive biosimilar development. Former FDA Commissioner Makary estimated these reforms could save manufacturers up to $150 million per drug and bring products to patients two to four years earlier. No biosimilar that has passed such analytical testing has ever failed to gain FDA approval, underscoring that clinical trials are an unnecessary redundant expense.
In October, the FDA issued guidance removing the typical need for comparative efficacy studies to support biosimilar applications, recognizing that modern analytics are sufficient for establishing biosimilarity. The agency is also working under BsUFA IV to set goal dates for biosimilar approvals once reference product exclusivity expires, though industry notes that expiration dates are often unknown.
Biosimilars currently cost about 15% to 35% less than brand-name biologics, and their introduction typically prompts brand manufacturers to lower prices. The biosimilar market has recently seen major brands such as Stelara, Prolia/Xgeva, Soliris, and Tysabri face competition, and first-time approvals for biosimilars to Xolair, Perjeta, and NovoLog have been granted. The Biosimilars Forum’s executive director noted that the administration of HHS Secretary Kennedy, CMS Director Oz, and FDA Commissioner Makary has been publicly supportive, emphasizing the importance of biosimilars for competition and cost savings. The FDA guidance also signals that interchangeability designations may no longer require separate switching studies, and legislative efforts are addressing pharmacy benefit manager reforms and interchangeability exclusivity removals to further facilitate biosimilar uptake.