FDA urges biosimilar makers to adopt alternatives to clinical efficacy trials

FDA's Office of Therapeutic Biologics and Biosimilars, led by director Sarah Yim, announced that the agency is working to help sponsors rely less on clinical efficacy studies when developing biosimilars.

The FDA is encouraging the use of alternative data, such as analytical and pharmacokinetic studies, to demonstrate that a biosimilar matches its reference product, which could shorten development timelines and reduce costs.

By providing these alternatives, the agency hopes to build greater confidence among clinicians and patients in biosimilar products and accelerate their market entry.