Samsung Bioepis' Trastuzumab Biosimilar, SB3, Approved in Republic of Korea

Samsung Bioepis announced this week that it has gained regulatory approval in the Republic of Korea for its trastuzumab biosimilar, SB3.

The Korea Herald reports that the biosimilar, referenced on Herceptin, was granted a marketing approval by the Korean Ministry of Food and Drug Safety for the treatment of metastatic breast cancer, early breast cancer, and metastatic gastric cancer. Samsung Bioepis plans to sell the drug under the brand name Samfenet. The next steps for the biosimilar developer are selecting a marketing partner for commercializing the drug and completing drug pricing procedures for the Korean marketplace.

The Republic of Korea has thus far approved 3 other biosimilars made by Incheon-based Samsung Bioepis: etanercept (referenced on Enbrel), infliximab (referenced on Remicade), and adalimumab (referenced on Humira). Samsung Bioepis has already launched its etanercept and infliximab products, but awaits Korean patent expiry of Humira—in January 2019—before it will begin to sell its adalimumab treatment.

SB3 also earned a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September 2017. If SB3 is granted a final marketing authorization by the European Commission, the company plans to sell the biosimilar in the European marketplace under the brand name Ontruzant. The drug will be marketed in Europe by MSD (known as Merck in the United States), and is poised to become the first biosimilar trastuzumab available in the European marketplace.

Meanwhile, the United States awaits a trastuzumab biosimilar of its own; while Samsung Bioepis has not announced a filing for SB3 with the FDA, the US regulatory body is currently reviewing a trastuzumab biosimilar, MYL-1401O, developed by Mylan and Biocon. Though the drug had a Biosimilar User Fee Act (BsUFA) target date of September 3, 2017, Biocon announced in late August that the FDA would not issue a regulatory decision on the product until December 3.