FDA commences review of Samsung Bioepis’ biosimilar SB8 for sales in US
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 (email@example.com)