9 March 2026 - The US FDA today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like “generic” versions of biologic drugs. In new draft guidance issued today, the agency recommended streamlining unnecessary clinical pharmacokinetic testing when scientifically justified. 

This change could save biosimilar developers up to 50% of their pharmacokinetic study costs, or approximately $20 million, and help lower drug costs.

Read FDA press release