The fourth Biosimilar User Fee Agreement (BsUFA IV) negotiations were only recently concluded, and the result poses new opportunities for biosimilar manufacturers. At last week’s GRx+Biosims meeting, several sessions touched on the significant changes to the program.
With a legislative approval deadline of September 30, 2027 looming, the FDA and the US biosimilar industry concluded negotiations for the BsUFA IV agreement; speakers at last week’s GRx+Biosims meeting in North Bethesda spelled out the most significant changes. This fourth iteration of BsUFA will apply to fiscal years 2028 through 2032.
Advancing Biosimilar Development, and With More Communication and Efficient Review
Although overall fees for a 351(k) application have not radically changed, some fee structure alterations are worth pointing out. First, all biosimilar product development (BPD) fees have been eliminated. Second, substantial discounts (50%) are offered for manufacturers planning to submit multiple 351(k) applications that contain the same drug substance information, to encourage simultaneous filing of those applications.
The FDA has also streamlined the number of supplement categories present in the current version of BsUFA, from six to two categories, with either four-month or six-month review timelines (for category 1 and 2 supplements, respectively). With respect to review timelines, BsUFA IV will permit the agency to extend deadlines up to 60 days beyond the goal date to address “discrete, late-arising, resolvable issues to help avoid otherwise unnecessary provisional determinations and complete response actions.” Furthermore, the FDA would implement a process for proactively communicating with the biosimilar manufacturer when an anticipated target action date is likely to be missed, with a new deadline date and informing the applicant of the reason for the delay. “This gives the FDA a bit of flexibility, with appropriate communication,” explained Sarah Yim, MD, Director, Office of Therapeutic Biologics and Biosimilars, at FDA.
Importantly, the biosimilar initial advisory (BIA) meeting has now been replaced with a type 2b BPD meeting as the manufacturer’s first interaction with FDA to describe a proposed biosimilar development program. Cory Wohlbach, Global Vice President, Global Biosimilars Regultory Affairs, Teva Pharmaceuticals, believes that BsUFA IV supports biosimilar development, “by allowing manufacturers to meet with the FDA early and often. It encourages companies to really push the envelope on the science during these meeting.” They are offering either type 2b meetings with a 90-day timeline or a “written review pathway” with a 60-day timeline to gain quicker feedback during important development phases.
Perhaps the most frequent reason for receiving an FDA complete response letter for biosimilar applicants is a deficiency at the manufacturing facility. FDA would like to reduce the number of facility-driven rejections, by offering more guidance on facility readiness prior to the 351(k) submission and after inspections.
Jessica Greenbaum, JD, Senior Director, Regulatory Affairs Policy, US, Sandoz, pointed out that the latest iteration of BsUFA does not require increased target revenue. “Eliminating the BPD fee may be a sign of maturity of the program.” When asked about one item on the industry’s wish list that was not included in BsUFA IV, she responded that the FDA’s process for determining exclusivity (and timelines) is too vague. She hoped that proposed legislation would address this short coming.