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# HELP Committee Advances Biosimilar Bill
- URL: https://www.fdaweb.com/help-committee-advances-biosimilar-bill/
- Published: 2026-07-23T12:00:00.000Z
- Updated: 2026-09-14T13:43:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161507

The Senate HELP Committee has voted unanimously to advance legislation sponsored by Sen. **Rand Paul** (R-KY) to streamline the biosimilar approval process. A [statement](https://www.paul.senate.gov/dr-rand-pauls-legislation-to-lower-drug-prices-unanimously-advances-out-of-committee/?ref=fdaweb.com) issued by Paul says the Expedited Access to Biosimilars Act would increase market competition, lower drug prices, and increase access to more life-saving treatments.

“FDA in previous administrations has forced companies to jump through bureaucratic hoops and produce redundant clinical studies that offer no new meaningful scientific information for the approval process,” Paul says. “My bill puts an end to wasteful and repetitive clinical requirements that create unjustified barriers, further delaying competition in the market. Biopharmaceutical researchers have argued that new and advanced methods of determining biosimilar clinical equivalence in early development have eliminated the need for late-stage human studies. When a biosimilar proves it is safe, effective, and similar to the brand-name product in the early stages of its analytical and safety assessment, there’s no scientific justification to delay access.”

The statement says the bill would:

- retain FDA requirements for pharmacokinetic and immunogenicity studies, but eliminate the requirement for pharmacodynamic and clinical efficacy studies since they would be unnecessary if the other tests were successful; and
- require FDA to justify the additional study requirements within 60 days of a biosimilar manufacturer’s initial meeting with the agency, ensuring that regulatory decisions are based on scientific necessity and not outdated bureaucracy.

Paul, who is a doctor, says FDA regulatory overreach “often dictates the practice of medicine and slows access rather than making safety and effectiveness determinations of medications. The agency’s increasing demands for studies leave little room for physicians and patients to make outcome-oriented decisions for themselves.”