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Mylan Reveals FDA Goal Date For Bevacizumab

Mylan And Biocon Weighing Up A Third Biosimilar Launch

 
• By Dean Rudge

Mylan and Biocon's global development alliance has so far led to two biosimilar launches in the US. A filing for a biosimilar of Genentech's Avastin (bevacizumab) submitted by Mylan may soon bring a third.

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Mylan's bevacizumab filing has been accepted for filing by the FDA • Source: Shutterstock

The US Food and Drug Administration has set a goal date under the Biosimilar User Fee Act of 27 December this year for Mylan and Biocon’s proposed biosimilar to Genentech’s Avastin (bevacizumab), following the FDA’s acceptance of Mylan’s biologics license application filing.

“The BLA seeks approval of bevacizumab for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; first-line use for patients with non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma in

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