FDA Urges Biosimilar Makers to Skip Efficacy Trials

FDA official Sarah Yim said clinical efficacy studies are no longer needed for most biosimilar development programs.

Updated on Nov. 5, 2026 in Biotech

Isometric editorial illustration of a laboratory bench with rows of unlabeled vials and a steel analytical column, in deep teal, slate, and cream. — The FDA said on Tuesday that most biosimilar drug makers no longer need comparative efficacy studies, urging reliance on analytical assessments instead. AI Illustration. Upload story photo >

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Should the FDA approve cheaper generic-style biologic drugs without new clinical trials?

Sarah Yim, director of the FDA's Office of Therapeutic Biologics and Biosimilars, urged sponsors to rely less on comparative efficacy studies during a fireside chat at the AAM GRx+Biosim conference. The agency's streamlined approach, announced in October 2025, could eliminate that requirement for most biosimilars.

Why it matters

Manufacturers could instead use comparative analytical assessments to establish biosimilarity, except where a comparative efficacy study is still required. Yim said such clinical studies are not helping biosimilar programs.

The BsUFA IV commitment letter consolidates six supplement categories into two, with review timelines of four and six months. The stub does not indicate how many biosimilar programs will still require comparative efficacy studies.

The players

Sarah Yim

Director of the FDA's Office of Therapeutic Biologics and Biosimilars, overseeing regulatory review of biologic and biosimilar products.

U.S. Food and Drug Administration

The federal agency responsible for regulating drugs, biologics, and biosimilars in the United States.

The details

The FDA will generate educational materials to make analytical data more understandable to sponsors. Yim hopes clinical studies will become less important to the field within ten years.

October 2025: FDA announces streamlined biosimilar development approach.
Late September 2026: FDA publishes BsUFA IV commitment letter.
Conference day, 2026: Yim speaks at the AAM GRx+Biosim fireside chat.

Tech Landscape

The BsUFA IV commitment letter, the user-fee reauthorization governing biosimilar review, consolidates six supplement categories into two with four- and six-month review timelines. The FDA's push to replace comparative efficacy studies with analytical assessments extends that reform to the substance of biosimilar approval itself.

Biosimilar pricing and availability for patients may shift as manufacturers adopt the streamlined pathway. The stub does not specify timelines for when these changes would reach pharmacies or insurance formularies.

The takeaway

Biosimilar developers should watch for FDA educational materials explaining how to use comparative analytical data under the new approach. Stakeholders can expect the agency's reliance on clinical efficacy studies to decline over the coming years.