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USFDA accepts Biocon-Mylan's Avastin biosimilar application for review

The application seeks approval of biosimilar bevacizumab for treatment of patients with metastatic colorectal cancer in addition to other ailments

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The biosimilar, the approval of which is expected by year-end, would be the third biosimilar from the partnered portfolio of Biocon and Mylan for cancer patients in the US.

Samreen Ahmad Bengaluru
In a positive for Biocon, US drug regulator USFDA has accepted a biologics licence application by biopharmaceutical major and partner Mylan for a proposed biosimilar to treat advanced colon or rectal cancer.

The application seeks approval of biosimilar bevacizumab for treatment of patients with metastatic colorectal cancer in addition to other ailments.

“Once approved, our proposed biosimilar bevacizumab will provide an affordable alternative to the branded biologic for the approved indications. Biocon Biologics’ strong R&D and manufacturing capabilities have enabled us to offer two key biosimilars to cancer patients in the US and bevacizumab will further expand our oncology portfolio,” said Christiane