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…