FDA’s BsUFA III Features

At last week’s DIA Biosimilar 2022 conference in Arlington, Virginia, speakers from the Food and Drug Administration (FDA) were optimistic that the current BsUFA III proposal would be voted on and signed into law shortly, and they focused on some of the larger issues addressed by the bill.

Jacqueline Corrigan-Currey, MD, JD, Principal Deputy Director at the FDA’s Center for Drug Evaluation and Review, and Sarah Yim, MD, Director of FDA’s Office of Therapeutic Biologics and Biosimilars pointed out that this latest 5-year authorization would set in motion several evolutionary changes in not only the interaction between manufacturer and the FDA, but also benchmarks for the evaluation of biosimilar applications, the validation of biosimilar-device combinations, and regulatory science programs.

BsUFA III Supplement Categories
Figure 1

One major improvement in BsUFA III is the setting of performance goals for several newly designated categories of biosimilar supplements (Figure 1). For example, for original and resubmitted category B supplements (i.e., adding an indication without new data requirements), FDA’s goal would be to make a decision within 4 months of the receipt date in 90% of the applications by fiscal year 2025. An initial determination of interchangeability (a category F supplement) would be made for 90% of the cases within 10 months of the application receipt by fiscal year 2025. The timeframe for decisions in resubmitted interchangeability applications would be within 6 months by 2025. Dr. Corrigan-Currey stated that “more supplements are being submitted to existing biosimilar applications and approvals. With BsUFA III, we hope to speed decisions on these supplements.”

BsUFA III timeline
Figure 2

Dr. Corrigan-Currey outlined myriad new guidances that will be produced with the authorization of BsUFA III, including an advertising guidance for promotional labeling and marketing for biosimilars designated as interchangeable (with the reference product) in 2024, advice for reporting postapproval manufacturing changes, and guidances on communication between the FDA and applicants (Figure 2).

“The passage of BsUFA III will fund up to 15 new staff positions at the FDA,” she added, which may also improve the agency’s capacity and efficiency. “Domestic inspections are now at pre-COVID-19 levels, and foreign facility inspections resumed in March 2022.”

Seeking to Clarify Interchangeability

Dr. Yim acknowledged that the interchangeability issue is still causing confusion among various stakeholders. This was further complicated by the approval of Coherus Bioscience’s interchangeable biosimilar version of ranibizumab Cimerli®. “Based on product-depending factors, scientific justification supported that a switching study was not needed,” said Dr. Yim, “and would not be informative.”

However, this seems a bit besides the point. Since Cimerli is a medical benefit or part B product, it would not generally be subject to automatic substitution at a pharmacy. Therefore, one has to separate the scientific justification for the designation and the practical use of the interchangeable designation. Frankly, this was difficult enough to communicate before Cimerli’s approval.

Dr. Yim commented, “The FDA is offering a series of continuing education courses through Medscape about biosimilars and interchangeable biosimilars,” which may provide clarity to several types of health professionals.

In Other Biosimilar News

Biogen’s lawsuit against Sandoz accused the biosimilar manufacturer of violating up to 28 patents on Biogen’s reference product Tysabri® for the treatment of multiple sclerosis. Filed earlier this month, the patent litigation raised some eyebrows, as the FDA had already accepted Sandoz and partner Polpharma’s 351(k) application for their biosimilar natalizumab. An FDA decision is expected in the second quarter of 2023. Patent litigation filings under the BPCIA most often occur well before this point in the development process.

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