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Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices biological product review process to make biosimilar biological product therapies available to patients sooner without compromising review quality or FDAs high standards for safety, efficacy, and quality. As part of FDAs agreements with industry during prior BsUFA authorizations, the Agency agreed to certain performance and procedural goals and other commitments. These goals apply to the process for the review of biosimilar biological product applications, including biosimilar biological product development meetings, review of applications and supplements, and other review activities. FDAs web page Biosimilar User Fee Amendments provides more information about BsUFA, including the statutory text of FDARA, the BsUFA commitment letter, Biosimilar Authorization Performance Goals and Procedures Fiscal Years 2013
through 2017 BsUFA Commitment Letter, key Federal Register documents, BsUFA-related guidances, BsUFA user fee rates, performance reports, and financial reports. The Agencys Biosimilar User Fee Amendments web page is available at https
www.fda.gov/industry/fda-user-feeprograms/biosimilar-user-feeamendments.
With the current authorization of BsUFA II under FDARA, FDA
implemented a review program the Program to promote the efficiency and effectiveness of the first cycle review process. The Program allows for additional communication between the FDA review team and applicants of biosimilar biological products, including mid-cycle communications and late-cycle meetings, while adding 60 days to the review clock to provide for this increased interaction and to address review issues. BsUFA II also includes commitments to advance development of biosimilar biological products through further clarification of the regulatory pathway that permits a biosimilar biological product to be licensed under section 351k of the Public Health Service Act, and to enhance capacity for biosimilar guidance development, reviewer training, and timely communication.
More information on these commitments can be found in the BsUFA II Commitment Letter at https
www.fda.gov/media/100573/download.
As part of the current authorization, FDA established an independent fee structure and fee amounts to improve program funding predictability, stability, and administrative efficiency.
The new structure established a BsUFA
target revenue based on BsUFA program costs and updated the overall fee
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structure and related financial mechanisms. The agreement also included commitments to enhance management of user fee resources through the development of a resource capacity planning capability and thirdparty evaluation of program resource management, management of the carryover balance, along with the publication and annual update of a 5year financial plan.
The current authorization also includes several commitments to improve the hiring and retention of critical review staff through modernization of FDAs hiring system, augmentation of hiring staff capacity and capabilities, creation of a dedicated function focused on staffing the program, reporting on hiring metrics, and a comprehensive and continuous assessment of hiring and retention. A
list of the deliverables developed to meet BsUFA II commitments is available on the FDA web page https
www.fda.gov/industry/biosimilar-userfee-amendments/completed-bsufa-iideliverables.
III. Proposed BsUFA III
Recommendations In preparing the proposed recommendations to Congress for BsUFA reauthorization, FDA conducted discussions with regulated industry members, as required by the law. We began the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input on the reauthorization and announcing a public meeting that was held on November 19, 2020. The meeting included presentations by FDA and a series of panels with representatives of different stakeholder groups, including patient advocates, consumer groups, regulated industry members, health professionals, and academic researchers.
The materials from the meeting, including a transcript and webcast recording, can be found at https
www.fda.gov/industry/biosimilar-userfee-amendments/public-meetingreauthorization-biosimilar-user-fee-actbsufa-11192020-11192020.
Following the November 2020 public meeting, FDA conducted negotiations with regulated industry from March 2021 through June 2021. As directed by Congress, FDA posted minutes of these meetings on its web page at https
www.fda.gov/industry/biosimilar-userfee-amendments/bsufa-iii-fiscal-years2023-2027.
The proposed enhancements for BsUFA III address many of the top priorities identified by public stakeholders, regulated industry, and FDA. While some of the proposed
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enhancements are new, many either build on successful enhancements or refine elements from the existing program. The enhancements are proposed in the following areas:
Supplemental applications, meeting management, best practices in communication between FDA and sponsors, inspections and alternative tools, interchangeable biosimilar biological product development, regulatory science, finance, hiring and retention, and information technology.
The full text of the proposed BsUFA III
Commitment Letter can be found on the Agencys web page BsUFA III: Fiscal Years 20232027, available at https
www.fda.gov/industry/biosimilar-userfee-amendments/bsufa-iii-fiscal-years2023-2027. Each significant new or modified enhancement is described briefly below:
A. Original and Resubmitted Supplemental Biosimilar Biological Product Applications To expedite the review of supplemental biosimilar biological product applications, FDA proposes to establish new supplement categories, timelines, and performance goals. New review timelines range from 3 to 10
months, depending on the content and category of the supplement submission.
Certain supplements for safety labeling updates and labeling updates to add or remove an indication that do not contain efficacy data sets would have shorter review timelines than supplements in other categories. These enhancements are described in section I.A.2 of the proposed BsUFA III
Commitment Letter.
B. Meeting Management Goals To improve overall meeting management, FDA proposes to modify the Biosimilar Initial Advisory BIA
meeting, create a new Type 2a meeting, and modify the timing of Type 4
meeting background packages. FDA
would not require the submission of preliminary comparative analytical data for a BIA meeting. The new Type 2a meeting would allow for quicker discussion on a narrow set of issues e.g., often one but no more than two issues involving no more than three review disciplines or divisions.
Traditional Type 2 meetings under BsUFA II would be renamed to Type 2b meetings in BsUFA III. Under this proposal, the Type 4 meeting background package may be submitted up to 14 calendar days after FDA
receives the meeting request. There would also be a new followup opportunity to pose clarifying questions after meetings or a written-response-

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