trastuzumab
Mylan and Biocon apply to FDA for biosimilar approval
January 12, 2017Sales and Marketing Biocon, FDA, Mylan, biosimilar, trastuzumab
Mylan, the US-based generics specialist, and Biocon, an Indian biopharmaceutical company, have applied for a biologics license application (BLA) for …
EMA accepts regulatory submission for proposed Herceptin biosimilar
August 26, 2016Medical Communications Biocon, EMA, Herceptin, Mylan, biosimilar, regulatory, submission, trastuzumab
Mylan and Biocon have announced that the European Medicines Agency (EMA) has accepted for review its marketing authorisation application for …
Phase III study confirms similarity of Herceptin biosimilar from Amgen, Allergan
July 22, 2016Medical Communications, Research and Development Allergan, Amgen, Herceptin, Roche, biosimilar, trastuzumab
Amgen and Allergan have announced the results from a Phase III study investigating ABP 980, their biosimilar candidate for Roche’s …
Mylan’s breast cancer biosimilar matches Roche’s Herceptin in Phase III trial
June 6, 2016Research and Development ASCO, Biocon, Herceptin, Mylan, Roche, biosimilar, breast cancer, trastuzumab
Mylan (NASDAQ: MYL) and Biocon (NSE: BIOCON) have presented data the 2016 American Society of Clinical Oncology (ASCO) annual meeting …
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