Biosimilar Sponsors May Be Going Overboard On Clinical Data, FDA Says

Studying multiple indications 'not the right way to approach biosimilars,' agency says; Amgen conducted more studies than needed for its proposed Humira biosimilar to enhance patient and physician confidence.

Some biosimilar product sponsors are doing more clinical studies than FDA believes necessary to support licensure.

"We are seeing biosimilar sponsors proposing to do multiple studies in multiple indications, which to us is not the right...

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 US FDA Performance Tracker

More from Regulatory Trackers