Two recent decisions by the European Medicines Agency’s Committee for Medicinal Products for Human Use are to be reviewed by the European regulator following requests to re-examine the CHMP opinions.
The decisions in question refer to the CHMP’s recommendation not to grant Prestige Biopharma a pan-European marketing authorization for its HD201 trastuzumab biosimilar and its recommendation to suspend the marketing authorizations of around 100 generics after identifying irregularities in