Biosimilar Sponsors Offer Advisory Committee Primer

Extrapolation, uncertainty could prove important when the Oncologic Drugs Advisory Committee considers Sandoz’s filgrastim biosimilar on Jan. 7.

FDA’s upcoming advisory committee meeting on Sandoz Inc.’s filgrastim biosimilar application likely will differ from the sessions many have come to expect and sponsors will be watching for the new details.

The meeting for FDA’s first biosimilar is scheduled for Jan. 7. The nature of the application means that there may be some divergence from the traditional advisory committee format and...

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