FDA urges biosimilar sponsors to use alternative efficacy studies while AI reshapes regulatory work

AI is becoming common in regulatory work. Experts say it will not replace regulatory professionals but will help them work more efficiently and free up time for human interaction. They stress that professionals must understand AI’s capabilities and limits.

In a recent statement, FDA’s Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars, said the agency is actively encouraging sponsors of biosimilars to rely less on traditional clinical efficacy studies.

The FDA hopes that using alternative data and methods will demonstrate comparability to reference products while building public confidence in biosimilars. Sponsors are urged to adopt these approaches as part of the agency’s broader effort to modernize the review process.