BsUFA: Industry seeks enhancements for next biosimilars program

Pharmaceutical industry representatives praised the US Food and Drug Administration’s (FDA) decision to eliminate the requirement for comparative clinical studies for most biosimilars during a meeting on Wednesday kicking off the reauthorization of FDA’s Biosimilar User Fee Amendments (BsUFA) program.

They also noted that the review process for biosimilars could be enhanced through early communication about deficiencies that need to be addressed, and emphasized that maintaining stability and predictability at FDA is essential for the program's success.

FDA and the regulated industry will now enter negotiations to develop a commitment letter for the fourth iteration of BsUFA, which will cover FY 2028-2032 and must be reauthorized before the current BsUFA III program expires at the end of FY 2027.

The public meeting was held to gauge the industry's response to the overall performance of the current BsUFA program; FDA is also seeking feedback on which elements should be retained, modified, or eliminated to improve the program.

Multiple industry representatives who spoke during the meeting praised the program's success in speeding up the development of biosimilars, which provide lower cost alternatives to biological drugs for consumers.

Scott Kuzner, senior director of sciences and regulatory affairs for the Biosimilars Council, said that BsUFA has played an “exceptional role in strengthening the biosimilar review process and helping ensure that patients have timely access to safe, effective and affordable medicines.”

Kuzner stated that there has been a “clear impact” from BsUFA since it began in 2012. FDA agency has since approved a total of 79 biosimilars, with 40 of those approvals occurring during BsUFA III alone; in 2025, FDA approved 16 biosimilars.

Industry reps applaud move to cut comparative efficacy studies

Industry respondents praised FDA’s decision to eliminate comparative efficacy studies and instead rely on the results of comparative analytical assessments (CAAs) to establish drug comparability, except in certain cases when a CES is still necessary. FDA announced this shift in October. (RELATED: FDA proposes to cut comparative efficacy study requirements for most biosimilars, Regulatory Focus 29 October 2025)

“FDA recognizes that comparative efficacy studies are often unnecessary as robust analytical pharmacokinetic data can already demonstrate biosimilarity. This shift represents a deep trust in science and a willingness to modernize the regulatory framework,” Kuzner said.

Aaron Josephson, senior director of global regulatory policy for Teva, also applauded the move. “FDA’s recent announcement was a welcome shift in policy that will lower development costs and therefore make biosimilar development more attractive…these are vital steps forward,” he said.

Industry criticism

Yet industry representatives said there was room for improvement in the program. Kuzner noted that “more needs to be done to tackle the biosimilar void.”

He cited a report, by IQVIA published in February 2025, which found that between 2025 and 2034, 118 brand-name biologic medicines will lose their patent protections, creating a market opportunity valued at approximately $234 billion. Yet as of mid-2024, biosimilars to just 12 of those products were in active development, leaving 106 with expiring patents that may face little or no competition.

Kuzner said that excessive review times are part of the challenge, especially since many submissions will no longer require comparative efficiency studies.

Josephson similarly shared some ways the program could be improved. He said that “several review issues warrant attention.” These include supplement review times, information requests, FDA’s timeframe for communicating deficiencies, and delayed requests for information.

He said that “we look forward to discussing with FDA what changes maybe be possible to address these challenges.”

Josephson suggested that FDA should communicate deficiencies in applications earlier, which he said could “significantly improve the review efficacy by providing more time for applicants to address these deficiencies.” FDA should also schedule and conduct preapproval inspections earlier to give industry more time to address observations earlier and expedite the approval of biosimilar applications, he said.

Regulatory stability

Juliana Reed, executive director of the Biosimilars Forum, stressed that stabilization at the FDA is important to ensuring the ongoing viability of the biosimilar program.

“One of the things that is really important to us is the stabilization of FDA” to ensure that the agency continues to receive continued funding of the program, and to ensure the quality and safety of products approved under the program.

Reed also said that FDA should no longer require biosimilar products to have a suffix follow the nonproprietary names. FDA requires a unique four-letter suffix for the nonproprietary names of all biosimilars approved in the US.

“I believe we can streamline the process and take away some of the things that are not necessary and not of value like the suffix….these are things that we do not need anymore and we have to review those and improve upon these.”

BsUFA: Industry seeks enhancements for next biosimilars program

Related topics

Recommended content

Welcome to the new RAPS Digital Experience