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# Praise for Biosim User Fee Agreement
- URL: https://www.fdaweb.com/praise-for-biosim-user-fee-agreement/
- Published: 2016-12-07T12:00:00.000Z
- Updated: 2026-09-14T21:53:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137507

Pharmaceutical Research and Manufacturers of America says the reauthorization of the Biosimilar User Fee Act for FY 2018-2022 (BsUFA 2) “provides the resources and support needed for FDA to achieve its core mission of protecting and promoting public health.” The association [says](https://www.regulations.gov/document?D=FDA-2015-N-3326-0029&ref=fdaweb.com) the reauthorization agreement will continue to build on the success of the agency’s biosimilar review program through new review enhancements that will help provide more predictable and timely access to biosimilar products. It also acknowledges the inclusion of other regulatory enhancements that it says will result in increased biopharmaceutical competition in the marketplace.

The Generic Pharmaceutical Association’s Biosimilar Council [comments](https://www.regulations.gov/document?D=FDA-2015-N-3326-0028&ref=fdaweb.com) that the agreement will strengthen the biosimilars program and will specifically address the council’s key goals in the negotiations: additional staff, finalization of outstanding policy guidance, increased communication with applicants, and biosimilars public education. It notes that fewer biosimilars are approved today than originally projected and that BsUFA 2 is designed to reverse this outcome.

Finally, Boehringer Ingelheim [says](https://www.regulations.gov/document?D=FDA-2015-N-3326-0026&ref=fdaweb.com) it welcomes the changes to the biosimilar review cycle laid out in the commitment letter, including the addition of 60 days to the review timeline, which gives FDA more time for review and should facilitate additional communication opportunities between FDA review teams and biosimilar sponsors. The company letter also discusses specific commitments it believes will meaningfully contribute to enhanced transparency, efficiency, and predictability.