The US Food and Drug Administration (FDA) Biosimilar User Fee Act (BsUFA) is due to be reauthorized for the second time (BsUFA III) in 2022. BsUFA allows FDA to collect fees from companies that are developing biosimilar and interchangeable products.
Dr Sarah Yim, Director of the Center for Drug Evaluation and Research (CDER) Office of Therapeutic Biologics and Biosimilars was recently interviewed on BsUFA reauthorization and discussed upcoming developments.
In the interview, Dr Yim noted that the purpose of BsUFA is to provide additional revenues which allow FDA to hire more staff, improve systems, and establish a better-managed biosimilar biological product review process. Together, these developments can make therapies available to patients sooner without compromising on safety, efficacy and quality. During each BsUFA reauthorization, the agency agrees to make specific improvements related to the review process for new biosimilar applications, resubmissions of original applications, and new and resubmitted supplements to approved applications.
Each incarnation of the BsUFA lasts for five years and the first reauthorization, BsUFA II, is set to end in 2022. The upcoming reauthorization will run from October 2022 through September 2027. Fees collected will go towards making continued improvements to the biosimilar and interchangeable product development and approval process.
Biosimilars, the BAP, and the Purple Book
In the interview, Dr Yim noted that biosimilars are safe and effective biological medications for treating many illnesses, from chronic skin diseases to cancer. They have potential to offer life-saving or life-altering treatments at reduced cost to patients. Biosimilars undergo a rigorous evaluation to ensure the safety and efficacy and must be manufactured in accordance with current good manufacturing practice (cGMP) requirements.
In addition, Dr Yim explained aspects of FDA’s Biosimilars Action Plan. She outlined how this is intended to help FDA develop biosimilars policies to make the development process more efficient and to facilitate greater competition in the biologicals marketplace. One of the key BAP deliverables is to enhance the Purple Book of licensed biologicals, so that it includes more information about approved biological products and also provides a modern, interactive user experience [1, 2]. BsUFA II intends to ensure that information about newly approved or withdrawn Biologics License Applications (BLAs) and about reference product exclusivity determinations is published in the Purple Book. As a result of these goals, FDA released a searchable, online database that contains information about approved biological products. ‘The Purple Book: Database of Licensed Biological Products’, . It is hoped that this will provide information to providers, pharmacists and patients.
Dr Yim outlined that BsUFA II included focus on:
- Making continued improvements to review processes and procedures
- Implementing an application review model for original 351(k) BLAs to promote the efficiency and effectiveness of the first cycle review process and to minimize the need for additional review cycles prior to approval
- Offering a clearer pathway for biosimilar biological product development, improved predictability and consistency across drug review processes
- Offering Americans increased access to safe, effective and high quality biosimilar and interchangeable biological products.
In addition, she noted that BsUFA II has identified areas and processes which can be further refined and gaps that need to be filled, and these can be addressed during reauthorization. In the reauthorization process, two key questions need to be asked:
- Looking at BsUFA II, what should be continued and what should be discontinued or changed, and how?
- What is missing that would facilitate the biosimilar and interchangeable biological product development programme to succeed in meeting its intended public health objectives?
BsUFA III virtual meeting
Dr Yim highlighted that there was opportunity for interested stakeholders to offer their views on BsUFA reauthorization during a virtual meeting that was held in November 2020 . This included presentations by FDA staff and panels representing multiple stakeholder groups. Public comments on this can be submitted up until 19 December 2020.
At the time of interview, the virtual meeting had not yet occurred, however, Dr Yim summarized that it was likely to include proposals regarding potential enhancements or efficiencies for the biosimilar product development and review process, additional proposals aiming to maximizing scientific and regulatory clarity, and other improvements. These could include a possible regulatory science programme to provide additional information that could enable more efficient safety or efficacy assessments that include data from real-world experience, pharmacodynamic biomarkers and immunogenicity response.
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1. GaBI Online - Generics and Biosimilars Initiative. FDA publishes historic drug approvals and searchable Purple Book [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/General/FDA-publishes-historic-drug-approvals-and-searchable-Purple-Book
2. GaBI Online - Generics and Biosimilars Initiative. FDA updated Purple Book database [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/General/FDA-updates-Purple-Book-database
3. U.S. Food and Drug Administration. Questions and Answers on Biosimilar Development and the BPCI Act [homepage on the Internet]. [cited 2020 Dec 11]. Available from: https://www.fda.gov/media/119258/download
4. GaBI Online - Generics and Biosimilars Initiative. FDA to hold public meeting on its user fee programmes [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Policies-Legislation/FDA-to-hold-public-meeting-on-its-user-fee-programmes
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