FDA cuts red tape to fast-track cheaper biosimilar drugs

The FDA will no longer require human trials proving biosimilars match brand-name biologics in safety and efficacy, a move expected to cut $100 million per drug in development costs and accelerate market entry.

Why it matters: This shift could expand access to lower-cost alternatives to expensive biologic drugs, which currently account for a major share of U.S. prescription drug spending but have seen limited price competition.

Backstory: Biosimilars were introduced to mimic the cost-slashing effect generics had on small-molecule drugs, but have struggled due to high development costs, regulatory hurdles, and resistance from brand-name drugmakers. Market share remains below 20%.

Zoom in: The clinical trials for biosimilars cost ~$24M and take 1–3 years, but new FDA guidance allows waiving trials if drugs are genetically uniform, highly purified, and analytically well-understood.

Big picture: By aligning biosimilar approval closer to the streamlined process for generics, the FDA aims to unlock broader competition, lower prices, and increased availability of critical treatments. Advocacy groups praised the move as a “watershed moment” for affordability.