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February 28, 2020

FDA commences review of Samsung Bioepis’ biosimilar SB8 for sales in US

PUBLISHED : November 21, 2019 - 15:44

UPDATED : November 21, 2019 - 15:44

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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 (ssh@heraldcorp.com)

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