On June 29, the Federal Register published the FDA’s request for comments concerning its statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original 351(k) Biologics License Applications.
On June 29, the Federal Register published the FDA’s request for comments concerning its statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original 351(k) Biologics License Applications (BLAs) submitted under the Public Health Service Act.
The newly proposed program is part of the FDA’s performance commitments made under the proposed reauthorization of the Biosimilar User Fee Act (BsUFA). The BsUFA, first passed into law in 2012, allows the FDA to collect user fees for the review of BLAs. If reauthorized, the act in its new form, BsUFA II, will allow the FDA to continue to collect such fees until 2022.
The FDA applies user fees to the review of applications through a variety of means, including the hiring of reviewers and support staff and the upgrade of its information technology resources. In its commitment letter, the FDA agrees to review performance goals associated with user fees, including the completion of applications and the taking of regulatory action within predictable timeframes. As part of its recommendations for BsUFA II, the FDA proposed a commitment to implement a review program for BLAs in order to minimize the number of review cycles needed for approval.
The new review program will facilitate additional communication between the agency and the applicant, and will further allow both parties to agree on a formal communication plan. The FDA says that an optimal review will allow for resolution of issues including labeling negotiation, risk evaluation and mitigation strategies, and post-marketing requirements and commitments that must be addressed before the agency can issue an approval.
The FDA seeks to evaluate the impact of the new program on the overall efficiency of application review; key objectives of the program’s assessment as described in the FDA’s statement of work include the following:
Comments on the Program for Enhanced Review Transparency and Communication for biosimilar products in BsUFA II will be accepted on Docket Number FDA-2017-N-3199 until July 31.
Meanwhile, the industry awaits congressional reauthorization of the BsUFA. Congress must reauthorize the BsUFA II prior to its summer recess if the act is to take effect in October as anticipated. A vote on reauthorization, which has bipartisan support, is expected in July.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
BioRationality: Commemorating the 15th Anniversary of the BPCIA
April 8th 2025Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.