South Korea’s Samsung Bioepis said Nov. 20 that the US Food and Drug Administration has started reviewing its application for sales of SB8, a proposed biosimilar referencing Avastin.
Samsung Group’s biosimilar development unit had applied for FDA’s marketing approval in September.
Avastin is a blockbuster biologics drug made by Genentech and sold by Roche. It prevents tumor growth by blocking the blood supply.
Its annual global sales average around 8.2 trillion won ($6.95 billion), 42 percent of which comes from the US market.
According to the Korean company, once the biosimilar hits the market it is expected to provide a more affordable treatment option for patients.
It would be Samsung Bioepis’ fifth biosimilar to receive the green light from the FDA.
It already sells a number of drugs in the US: Renflexis, a biosimilar of Janssen Biotech’s blockbuster immunology medicine Remicade; Enbrel biosimilar Eticovo; Ontruzant, a biosimilar product referencing Switzerland-based Roche Holding’s Herceptin; and Etanercept, a biosimilar referencing the immunology drug Enbrel developed by US-based Amgen.
The company is also planning to launch SB8 in the Europe and applied for sales approval from the European Medicines Agency in July.
By Song Seung-hyun (firstname.lastname@example.org)