After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

Accord Healthcare has been told by the FDA that its generic version of Astellas Pharma’s Prograf capsules will no longer be automatically substituted for the brand following a series of post-approval studies dating back more than a decade.

Reports have named Intas as another possible buyer for Biogen’s biosimilars business, following earlier rumors that Samsung Bioepis could be interested in a deal. Generics Bulletin spoke to both Intas and Biogen for their reaction.

Marketing applications for MenABCWY, zolbetuximab, crovalimab, macitentan/tadalafil, Coacillium, mRNA-1345, dasiglucagon and ustekinumab have been submitted to the European Medicines Agency for review.