FDA to Ease Copycat Drug Rules, Speeding Access to Cheaper Drugs

Key Takeaways

Federal regulators will no longer require costly clinical trials for most biosimilars, speeding up approval

The change could cut timelines in half and save drugmakers tens of millions in costs

Officials say this will boost competition and lower drug prices for patients

FRIDAY, Oct. 31, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) announced Wednesday that it will relax certain rules for approving low-cost versions of some high-priced medications, in an effort to speed up access to cheaper alternatives.

The decision affects biosimilars — medicines that are near-identical copies of biologic drugs made from living cells.

These drugs are similar to generics but more complex to produce. They’re often used to treat serious conditions like cancer, diabet