On Oct. 29, 2025, the U.S. Food and Drug Administration (FDA) announced it is aiming to reduce the number of human clinical studies required for approval of certain biosimilar drugs and cut development costs for the medicines made using living cells.

The agency released draft guidance proposing ways to accelerate the availability of less expensive close copies of complex biotech medicines and treat them like generics, enabling doctors to prescribe them more easily.

The move is part of a broader push to cut healthcare costs, U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. said in a press conference.

“Under this new framework, companies may not always need to conduct large, expensive human trials when advanced testing can already prove that biosimilars work just as effectively and just as safely as the original drug,” Kennedy said.

Unlike cheap generic versions of simple-to-manufacture pills, medicines made from living cells cannot be exactly copied, so are referred to as biosimilars. Major pharmaceutical companies and industry groups have lobbied against such changes that they argue could hurt innovation and limit treatment options.