FDA tweaks biosimilar fee paperwork: Comment by March
Published Date: 2/3/2025
Notice
Summary
The FDA is updating its paperwork rules for companies making biosimilar drugs—these are medicines very similar to already approved ones. They’re asking for public comments by March 5, 2025, before finalizing the changes. This update helps keep the biosimilar approval process smooth and supports fees that fund FDA’s review work.
Analyzed Economic Effects
6 provisions identified: 1 benefits, 5 costs, 0 mixed.
BsUFA III Fee Authority Through 2027
The FDA is authorized to assess and collect biosimilars user fees under the Biosimilar User Fee Amendments of 2022 (BsUFA III) from October 2022 through September 2027. Companies developing or applying to license biosimilar products may be required to pay these user fees as part of the program.
Estimated Increased Paperwork Burden
The FDA estimates the total annual reporting burden for the biosimilars information collection is 26,055 hours across all respondents, reflecting an overall increase of 13,069 hours and 105 responses annually. This increase mainly reflects more submissions, including pediatric study plans and other application-related materials.
Pediatric Study Plan (iPSP) Submission Expectation
FDA plans to issue draft guidance on 'Pediatric Study Plans for Biosimilar Products' and estimates that submission of pediatric assessment information (initial pediatric study plan, iPSP) averages 38.18 hours per submission. Sponsors developing proposed biosimilars may need to submit iPSPs or amendments as recommended in guidance.
Mandatory Form FDA 3792 Submission
Each new biological product development (BPD) entrant or new biologics license application (BLA) applicant must submit Form FDA 3792, the Biosimilars User Fee Cover Sheet, electronically at https://userfees.fda.gov/OA_HTML/bsufaCAcdLogin.jsp. The form takes about 0.5 hours (30 minutes) per submission on average and triggers an emailed notification with information about annual program fees.
Small Business Waiver Submission Rule
Companies seeking a small business waiver or refund may use Form FDA 3971 and should submit it by email to [email protected] at least 4 months before submitting their application to see if they qualify for a waiver. This process can affect whether a sponsor must pay user fees for a biosimilar application.
Patent Infringement Notification Requirement
If a biosimilar applicant is served with a complaint for a patent infringement action described in section 351(l)(6) of the PHS Act, the applicant must provide the Secretary of HHS with notice and a copy of the complaint within 30 days of service. FDA will publish notice of such complaints in the Federal Register under section 351(l)(6)(C).
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