FDA Streamlines Biosimilar Development Guidance

Sat, 14 Mar 2026 15:49:42 +0000
Pharmaceuticals

The FDA issued draft guidance to streamline biosimilar development by recommending the reduction of unnecessary clinical pharmacokinetic testing when scientifically justified. This initiative aims to save developers up to 50% in PK study costs, potentially lowering drug prices and increasing patient access to affordable biologic treatments.