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Biocon & Mylan’s biosimilar ‘Trastuzumab’ gets approval from Brazilian regulator

Co-developed by Biocon and Mylan, this is the first biosimilar Trastuzumab to be approved in Brazil and is indicated for the treatment of overexpressing HER2­positive metastatic breast cancer. The product will be marketed by the Libbs Farmaceutica........

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.....