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.

Sandoz looks to be in line for an EU-wide approval for its trastuzumab biosimilar during 2023, with the backing of the EMA’s Committee for Medicinal Products for Human Use.

The European Medicines Agency has OKd nine new medicines for EU-wide approval, but recommended against renewing the conditional marketing authorization of two drugs. 

CEO of Enzene Biosciences weighs in on the impact of Medicare negotiations in the US on the biosimilars market even as a US filing is planned for a Prolia biosimilar. In the interview, he says Enzene “is not afraid or concerned” over ongoing litigation with Merck KGaA over an Erbitux biosimilar in India, adding that new modalities like ADCs are being “seriously” considered.