US FDA accepts Amneal’s Biologics License Application for Bevacizumab
Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA
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Browsing Tag
Biologics License Application
US FDA accepts biologics license application from Lupin for pegfilgrastim biosimilar
This BLA expands the company's oncology portfolio
USFDA defers action on BLA for Avastin biosimilar, notifies Biocon Biologics, Mylan
To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the…
US FDA accepts Mylan and Biocon’s proposed biosimilar bevacizumab for review
The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is December 27, 2020 Biocon and Mylan announced that the US…