Generics Bulletin recaps the most recent regulatory news and updates from the FDA.

Samsung Bioepis and partner Sandoz have won approval for a third US Stelara biosimilar. Meanwhile, in Europe Celltrion has become the latest firm to qualify for an ustekinumab marketing authorization.

Phase IIb data for Auxora in an acute pancreatitis subpopulation is expected to set up the CRAC channel inhibitor for Phase III in that indication while suggesting positive read-through for AKI.

Regeneron’s lynchpin US formulation patent for its Eylea 2mg appears to remain a thorn in the side for biosimilar sponsors, as Samsung Bioepis joins Biocon in being blocked from launching its US FDA-approved biosimilar to the near $6bn eye-disease biologic.