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.
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.
