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FDA, Industry set priorities for BsUFA III

Posted 19 November 2020 | By Michael Mezher 

FDA, Industry set priorities for BsUFA III

At the kickoff meeting for the reauthorization process for the Biosimilar User Fee Act (BsUFA III) program, the US Food and Drug Administration (FDA) and industry shared their wish lists for the third iteration of the agency’s biosimilars review program.
While FDA laid out four broad goals for the FY2023-2027 program, industry presented more specific proposals, including the creation of a new pre-development meeting and issuance of further guidance on interchangeable biosimilars.
Reauthorization and FDA overview
The meeting, which sets the stage for the monthslong negotiations between FDA and regulated industry, began with an overview of the BsUFA program by Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research (CDER) and Andy Kish, director of the Office of Program and Strategic Analysis at CDER.
“The purpose of this public meeting is to collect a wide variety of stakeholder perspectives as we consider what to retain and what to change in the next iteration of BsUFA,” Cavazzoni said.
Under the first two BsUFA programs, “FDA has increased the predictability of the biosimilar review process, increased communication and transparency during biosimilar development and the application review and helped advance biosimilar marketplace competition, product access to patients and consumer choice via product approval,” she added, noting positive feedback from industry on the agency’s transparency and communication in the current program.
So far, FDA has approved 28 biosimilars since the inception of the 351(k) pathway, 18 of which have seen commercial launches. While the US trails behind Europe in terms of the number of approved and marketed biosimilars, Kish pointed out that the number of biosimilars in development has steadily increased under BsUFA I and II, with more than 100 products enrolled in the agency’s biosimilar development program in 2020.
Kish pointed out that the BsUFA program, now entering its ninth year, is much smaller and less mature than the Prescription Drug User Fee Act (PDUFA) program, which has spanned nearly three decades. “Somewhat similar to other programs, user fee revenue has outpaced budget authority available for the program,” Kish said, noting that in FY2021 the agency’s target user fee revenue for the program is $42 million.
“We are on track to meet our core performance goals for FY2020. We just closed out FY2020 and those numbers are being finalized and from current performance, it looks like we are on track to meet those performance goals,” Kish said.
As with the PDUFA program, meeting management continues to be a pain point for the BsUFA program, Kish said, noting that some of the meeting types the agency is missing its goals for are “quite small numbers, so you might miss one or two and you miss the goal.”
“It’s also important to note that the folks that are managing this and holding these meetings are also on the new drugs side, so their meeting management workload can’t be looked at in isolation. It’s also the workload that we have on the new drug side,” Kish said.
For BsUFA III, Kish said FDA’s high-level priorities are ensuring stable funding for the program; enhancing regulatory predictability and efficiency; enhancing operational capabilities, efficiency and agility; and facilitating more efficient biosimilar development.
Industry’s wish list
Representatives of industry bodies and biosimilar manufacturers drew up their own set of goals for the upcoming program.
While praising the progress made under BsUFA II, Meaghan Smith, executive director of the Biosimilars Forum, said that improving the efficiency and utility of meetings and communications with FDA is a top priority going forward.
Smith suggested this could be done by creating a new avenue for pre- or early-development meetings between biosimilar developers and FDA and by giving sponsors a mechanism to obtain clarification on advice or comments from FDA during meetings.
Cory Wohlbach, global vice president of biosimilar regulatory affairs at Teva Pharmaceuticals, speaking on behalf of the Association for Accessible Medicines’ Biosimilars Council, also called for “more opportunities for biosimilar sponsors and FDA to interact as early in the development process as possible without the need for additional analytical data.”
“An early meeting that occurs even before a sponsor has initial analytical data could be useful to discuss early development in order to obtain FDA input on key issues such as clinical endpoints and study design which are currently not as well supported by the meeting structure under BsUFA II,” Wohlbach said.
Smith, Wohlbach and others stressed the need for more clarity from FDA on biosimilar interchangeability and postapproval changes for chemistry, manufacturing and controls (CMC) and labeling.
“Industry continues to struggle with the lack of clarity regarding the agency’s policy on certain aspects of interchangeability as well as regulatory expectations for certain postapproval changes for biosimilar or interchangeable products,” Smith said, noting that interchangeable biologics have been excluded from several biosimilars guidances. “We appreciate that these exclusions may have been necessary at that time because the initial core interchangeability guidance had not yet been issued; however, it’s now an appropriate time to fill in those gaps.”
While FDA has yet to approve any interchangeable biosimilars, Wohlbach said that “clarifying guidance to industry on remaining issues will significantly facilitate development and regulatory review,” and noted that he expects the first interchangeable biosimilars to be approved under BsUFA III.
Smith and Wohlbach also called for FDA to establish a regulatory science initiative for biosimilars, as it has done for generic drugs, and to look into ways to promote global biosimilar development programs.
Smith said she would like to see “a more active implementation of the mutual recognition agreement [MRA] with the EU for preapproval inspections,” referencing the agency’s MRA with EU regulators for good manufacturing practice (GMP) inspections. (RELATED: US and EU fully implement mutual agreement on GMP inspections, Regulatory Focus 12 July 2019).
While Wohlbach sought more harmonization with other regulators to facilitate global development programs. “We believe that there is an opportunity for global development programs for biosimilars with a clearly understood mechanism of action, a thorough analytical characterization and human pharmacokinetics and immunogenicity data, without routinely requiring clinical efficacy studies,” Wohlbach said.
Both Cartier Esham, vice president for emerging companies at the Biotechnology Innovation Organization (BIO), and Lucy Vereshchagina, vice president of science and regulatory advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA) said they would like to see improvements in hiring and retention and upgrades to the program’s information technology infrastructure under BsUFA III.
Sundar Ramanan, global head of regulatory affairs at Biocon, suggested several changes for BsUFA III that would speed the regulatory review times for biosimilars and called on FDA to reconsider the need for biological products to have a suffix following their nonproprietary names. Ramanan said the agency should consider shorter review times for biosimilars that do not require a comparative clinical trial and proposed an accelerated review for biosimilars referencing products with no biosimilar competition.
“To support further competition for molecules with limited or no biosimilars, we request the agency to consider a shorter review timeline for the first biosimilar application,” Ramanan said.


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