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# FDA Suggests Biosimilars Review Model in BsUFA 2
- URL: https://www.fdaweb.com/fda-suggests-biosimilars-review-model-in-bsufa-2/
- Published: 2016-04-28T12:00:00.000Z
- Updated: 2026-09-14T20:58:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135518

FDA and industry negotiations for Biosimilars User Fee Act 2 reauthorization started considering 3/31 an agency application review enhancement proposal based on a model followed by CDER under the Prescription Drug User Fee Act. Meeting [minutes](http://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM497003.pdf?ref=fdaweb.com) show that agency representatives said that such a model could promote the efficiency and effectiveness of the first-cycle review process for biosimilars and minimize the number of review cycles necessary for approval. Major elements of the model include mid-cycle communication, a late-cycle meeting, and a review clock that begins on the 60-day filing date.