Tag: Accepted
USFDA accepts Mylan & Biocon’s proposed biosimilar Pegfilgrastim for review
The development marks the second successful biologics license application (BLA) for filing of the partnership in the United States of America...
US-FDA accepts Mylan & Biocon’s joint application on biosimilar Trastuzumab
While the Biologics License Application (BLA) for MYL-1401O has been accepted by the United States FDA, if approved, it has the potential to be the first biosimilar Trastuzumab in the US....