The Cancer Letter

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Drugs & Targets

EMA accepts for review Mylan’s MAA for a proposed biosimilar trastuzumab

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MYLAN N.V. and Biocon LTD said the European Medicines Agency accepted for review Mylan’s Marketing Authorization Application for a proposed biosimilar trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics and confirmatory efficacy/safety global clinical trials for...

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