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# Biosimilar Review Transparency Comment Sought
- URL: https://www.fdaweb.com/biosimilar-review-transparency-comment-sought/
- Published: 2017-06-28T12:00:00.000Z
- Updated: 2026-09-14T22:32:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139046

FDA is publishing a *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-13609.pdf?ref=fdaweb.com) soliciting comment on a statement of work for assessing the Program for Enhanced Review Transparency and Communication for 351(k) biosimilar applications. The program is part of agency performance commitments under the proposed reauthorization of the Biosimilar User Fee Act for 2018-2022.

The notice says the proposed new review model “will allow for additional communication between FDA review teams and the applicants of biosimilar biological products in the form of Biological Product Development Type 4 (pre-351(k) BLA) meetings, mid-cycle communications, and late-cycle meetings. To accommodate this increased interaction during regulatory review and to address the need for additional time to review these complex applications, FDA’s review clock will begin after the 60-day administrative filing review period for applications reviewed under the program.”

According to FDA, the program’s goal is to improve the efficiency and effectiveness of the first-cycle review process by increasing communications during application review. “This will provide sponsors with the opportunity to clarify previous submissions and provide additional data and analyses that are readily available, potentially avoiding the need for an additional review cycle when concerns can be promptly resolved without compromising FDA’s standards for approval,” it concludes.