The Biosimilar User Fee Act of 2012, which authorized the FDA to collect fees from biosimilar drug manufacturers to expedite their applications, is due to expire at the end of September.
The Biosimilar User Fee Act of 2012 (BsUFA), which authorized the FDA to collect fees from biosimilar drug manufacturers to expedite their applications, is due to expire at the end of September. To continue the user fee program and facilitate patient access to safe and effective biosimilar drugs after the 5-year period of the BsUFA, the FDA sought reauthorization of the act under slightly modified terms.
After the FDA held meetings to renegotiate an extension of BsUFA (known as BsUFA II), Senate and House bills to reauthorize user fee programs were passed out of committee in May and June, respectively. The 2 bills will proceed to the House and Senate floors for further debate and possible changes, but the act will need to be authorized before Congress enters its August recess in order to avoid interruptions to the FDA.
In a review of BsUFA II legislation, Aiding Harston of Rothwell, Figg, Ernst & Manbeck, PC highlighted some key differences between the new act and its predecessor. Among the most important considerations for industry include the following:
New Timeframes
BsUFA II extends the FDA’s goal time to review and take action on 90% of applications for biosimilars. While BsUFA I set a goal of reviewing and acting on such applications within 10 months of receipt, BsUFA II begins the 10-month clock on the date on which the applicant receives notice that its application has been accepted for review. This change extends the goal action date by 60 days, making the period from application to possible approval 1 year at the earliest. The aim of this extension is to provide more time for communication with the applicant and for inspection of manufacturing facilities.
Better Communication
BsUFA II provides for a new review model that seeks to minimize the number or review cycles needed for approval of a drug, to provide more time and resources to the FDA during the review process, and to facilitate additional communication between the applicant and the agency. While that added communication is welcome news to applicants, the new protocol also seeks to deliver more information to other stakeholders. The plan will allow for greater distribution of information to the public to improve understanding of biosimilars, clarify regulations for all biosimilar developers, and deliver more information related to dates of patent exclusivity for reference products.
More Guidance
BsUFA requires the FDA to publish revised draft guidance on its Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants and to update draft guidance on Brest Practices for Communication Between IND Sponsors and FDA During Drug Development in 2018, as well as to publish draft guidance—some of which it has published already—on a range of topics, including interchangeability, clinical pharmacology data to support biosimilarity, nonproprietary naming of biologics, statistical approaches to evaluate analytical similarity, processes and considerations related to post-approval manufacturing changes for biosimilars, and labeling for biosimilars.
Higher Fees
BsUFA II drastically increases the fee amounts. Under BsUFA II, base user fees are set to generate $45 million in revenue by 2018 (an increase of 125% on revenue in 2017). However, the Trump Administration’s budget proposes even further increases; with HHS cuts estimated at $15.1 billion, the Trump budget would compensate for such cuts by requiring industry fees to fund 100% of costs for the premarket review and approval of biosimilars.
Thus far, the committees that have passed the bipartisan House and Senate bills to renew biosimilar user fees have been reluctant to embrace the administration’s requests, and even more reluctant to entertain the idea of renegotiating user fees that were arrived at through the lengthy series of FDA meetings.
As the Regulatory Affairs Professionals Society pointed out in April, if Congress does not reauthorize the BsUFA and other user fee legislation prior to August, the FDA could be forced to lay off more than 3000 workers, significantly hampering the organization’s ability to approve new drugs in a timely fashion.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.