European Medicines Agency approves Mylan's Marketing Authorisation Applications for both biosimilars
Biocon announced that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorisation Applications (MAA) for proposed biosimilar Trastuzumab and proposed biosimilar Pegfilgrastim.Trastuzumab is used to treat certain HER2-positive breast and gastric cancers. Pegfilgrastim is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.
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