Days After US Aflibercept Approval, Sandoz Is Hit By Regeneron Lawsuit

Days after Sandoz received US FDA approval for its Enzeevu aflibercept biosimilar, Regeneron sued alleging that Sandoz failed to follow the “patent dance” set out in the BPCIA framework and claiming infringement of multiple patents on its Eylea.

Eye with reflection of word "legal"
Regeneron said Sandoz has not followed the BPCIA’s “patent dance.” • Source: Shutterstock

A few weeks after the US Food and Drug Administration approved Sandoz’s Enzeevu (aflibercept-abzv) biosimilar of Regeneron’s Eylea, the originator sued Sandoz alleging the firm failed to comply with the “patent dance” information-exchange requirements of the US Biologics Price Competition and Innovation Act, arguing that it was only able to confirm Sandoz’s aflibercept filing on the day of its clearance.

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 Biosimilars

More from Biosimilars & Generics