Samsung Bioepis cancer drug under review by FDA

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Samsung Bioepis cancer drug under review by FDA

Samsung Bioepis said Wednesday that the U.S. Food and Drug Administration has begun reviewing its license application for a cancer-fighting biosimilar called SB3.

A biosimilar is a drug with active properties similar to a previously licensed one. SB3 references Herceptin, a breast cancer drug from Swiss pharmaceutical company Roche.

According to Samsung Bioepis, SB3 is the company’s first oncological biosimilar submitted for regulatory review in the United States.


By Kim Jee-hee

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