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

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 (CEO), 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. Biocon, in 2019, had earned 27 per cent of its overall revenue from biosimilars. The Bengaluru-based company has set an ambitious target of $1 billion in sales through its biologics division by FY22.

Biocon had, in December last year, launched trastuzumab biosimilar Ogivri in the US market, which is a biosimilar to herceptin, and was co-developed by Biocon Biologics and Mylan.

Herceptin has sales of around $2.9 billion in the US. The biosimilar, used to treat breast cancer and gastric cancer, was rolled out at a competitive discount for customers to help ensure access. 

In 2018, too, Biocon had launched fulphila, a biosimilar pegfilgrastim, which is used to stimulate the bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. Biocon Biologics currently has a product pipeline of 28 critical molecules, of which it partners with Mylan for 11 of them. According to experts, launch of another biosimilar, insulin glargine, likely in the US this year, could provide another booster dose to the Biocon-Mylan partnership.

US-headquartered Mylan has been following a partnership strategy with domestic companies, including Biocon and Natco, in order to control R&D costs. The company also pitches for the government to incentivise R&D activities in the country. 

BOOSTER DOSE

Biocon and Mylan have a product pipeline of 11 biosimilars

2018: Pegfilgrastim biosimilar rolled out in US; treats infection in patients undergoing chemotherapy

2019: Trastuzumab biosimilar launched in US; treats breast cancer and gastric cancer

2020: Insulin glargine biosimilar likely to be approved in US in the second half of this year