Novartis division resubmits USFDA application for biosimilar Pegfilgrastim Farhat Nasim4 April 2019 9:15 AM ISTNew Delhi: Novartis division, Sandoz, recently announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar...
USFDA approves Mylan, Biocon's Fulphila, the first biosimilar to Neulasta Ruby Khatun Khatun6 Jun 2018 10:30 AM ISTHERTFORDSHIRE/PITTSBURGH and BENGALURU: Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's...
EMA accepts marketing authorization applications of Mylan and Biocon for 2 biosimilars Ruby Khatun Khatun2 Dec 2017 10:00 AM ISTHERTFORDSHIRE, England, PITTSBURGH and BENGALURU: Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency (EMA) has accepted for...
Mylan seeks EMA approval for 2 biosimilars Ruby Khatun Khatun9 Nov 2017 10:32 AM ISTNew Delhi: Biocon said that its partner Mylan has re-submitted marketing authorization applications with the European Medicines Agency for two...