Mylan and Biocon submit marketing application to EMA for biosimilar Pegfilgrastim

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Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency accepted a Marketing Authorization Application for Pegfilgrastim, a proposed biosimilar for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, with the exception of chronic myeloid leukaemia and myelodysplastic syndromes. In...

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