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

FDA to Ease Copycat Drug Rules

The US Food and Drug Administration (FDA) announced it will relax rules for approving low-cost versions of high-priced medications, speeding access to cheaper alternatives.

Developers of biosimilars, near-identical copies of biologic drugs, will no longer need clinical trials to prove effectiveness.

The FDA's decision affects biosimilars, medicines that are near-identical copies of biologic drugs made from living cells.

Author's summary: FDA eases biosimilar rules for cheaper drugs.

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MPR MPR — 2025-11-03

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