USFDA accepts Biocon-Mylan drug application for colon cancer

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 Hamacher, chief executive officer, Biocon Biologics.

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. It is currently available in India and other developing markets.

Swiss drugmaker Roche markets bevacizumab under brand name Avastin. The drug had garnered about $7.3 billion in sales in 2019. Amgen and Allergan, too, had launched Mvasi, a bevacizumab biosimilar in the US last year and has been selling the product 15 per cent lower than Roche’s Avastin.

According to an EY report, India is likely to capture about 8 per cent of the global $62 billion biosimilar market by 2025.

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Nitin Jain

A finance professional with around 20 years of investing experience in Indian markets both on buy and sell side, equity and debt, private and public with some of the best organizations globally including Goldman Sachs, ICICI Group, ICRA and others. He is a All India Silver Medalist CA by qualification.