Biocon, Mylan N.V. receive positive CHMP opinion for Ogivri

Biocon and Mylan N.V. have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri, a biosimilar to Roche’s Herceptin (trastuzumab). The positive CHMP opinion is based on data submitted as part of the Marketing Authorization Application which included similarity assessment in … Read more

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