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Biocon & Mylan’s proposed biosimilar ‘Trastuzumab’ gets USFDA nod

The US-FDA Oncologic Drugs Advisory Committee has unanimously recommended approval of Mylan and Biocon’s proposed cancer targeting biosimilar, Trastuzumab.............

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....

Mylan & Biocon announce first joint USFDA submission for biosimilar, Trastuzumab

Besides being an important milestone of Biocon and Mylan's joint global biosimilars program, the first biosimilar trastuzumab if approved by the top regulator.....