FDA to Fast-Track Biosimilars, Cuts Clinical Trial Barriers for Biologic Generics

The Food and Drug Administration (FDA) is preparing to accelerate the approval process for biosimilar drugs—cheaper versions of complex biologic medicines. 

Under the plan, companies may need fewer human clinical trials to prove similarity, relying more on analytical testing instead. 

Biologic drugs account for only about 5% of prescriptions in the U.S., yet they make up over half of total drug spending. 

The move comes amid pressure to lower healthcare costs. Supporters say it will boost competition and access to medicines. Critics—mainly large pharma companies—warn it could reduce incentives for innovation. 

Generic-drug makers and biosimilar developers welcomed the shift, noting the high cost and long timeline that has slowed biosimilar entry. 

While the policy guidance is still in draft form, the change signals a major regulatory shift. Final rules may appear within months, subject to public comment.