FDA proposes streamlined biosimilar testing

The FDA released draft guidance on Oct. 29, 2025 to simplify studies for biosimilar versions of biologic drugs, aiming to remove what it calls unnecessary, resource‑intensive clinical comparisons. The proposal opens a 60‑day public comment period, with non‑binding final guidance expected in three to six months, and federal officials say the change is intended to spur competition, lower prices, and speed access to treatments such as those for autoimmune disease and cancer.