FDA moves to slash drug costs by streamlining biosimilar approvals

WASHINGTON, D.C. —The U.S. Food and Drug Administration (FDA) announced significant policy changes on Wednesday aimed at accelerating the approval of biosimilars—the cheaper, “generic” alternatives to expensive biologic drugs—in a bid to lower health care costs for Americans significantly.

Biologic drugs, which treat complex illnesses like cancer and autoimmune diseases, account for over half of total U.S. drug spending despite making up only 5% of prescriptions.

The FDA’s new draft guidance proposes a significant reduction in the regulatory burden for manufacturers:

Scrapping Clinical Trials: The new guidance generally proposes eliminating the requirement for extensive, comparative human clinical efficacy studies to prove a biosimilar is highly similar to its brand-name reference pro