Biosimilar Draft Guidance Outlines Three-Arm Bridging Studies For Non-U.S. Products

Clinical pharmacology data could help biosimilar sponsors pursue a more global development plan.

Biosimilar sponsors using reference products licensed outside the U.S. will need bridging data that is likely to include pharmacokinetic data from the biosimilar product, the U.S.-licensed reference product, and the non-U.S. licensed product, FDA says in a new biosimilars draft guidance.

The draft guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product,” is intended...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

More from North America