Samsung Bioepis Co., a joint venture between South Korea’s Samsung BioLogics Co. and U.S.-based Biogen Inc., has received marketing approval of Samfenet, a trastuzumab biosimilar, from Korean health authorities, Samsung BioLogics said in a regulatory filing on Thursday.
The biosimilar, SB3, referenced on Roche`s Herceptin, is Samsung’s first approved oncology drug and is indicated for the treatment of patients with primary and metastatic breast and gastric cancer.
Herceptin generated global sales of nearly $7 billion in 2016 for the Swiss pharmaceutical giant. It was the eighth best-selling drug in the world.
A Samsung Bioepis official said "Samfenet will be launched in Korea after its local distributor is determined with a drug price.
In September, Samsung Bioepis received a positive opinion from the EMA`s Committee for Medicinal Products for Human Use on approval of Samfenet under a brand name of Ontruzant in Europe. The company expects it to be approved as early as this month.
By Kim Hye-soon and Minu Kim
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