Mylan and Biocon Announce Positive CHMP Opinion for Ogivri®, Biosimilar Trastuzumab
(WorldNews Netherlands)

HERTFORDSHIRE, England, PITTSBURGHand BENGALURU, India, Oct. 19, 2018/PRNewswire / -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today 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 analytical testing, preclinical and clinical studies. Results demonstrated no clinically meaningful differences in quality, potency and safety; therefore, establishing...