Samsung Bioepis Launches 'Ontruzant' in the US 15 Months After Sales Approval

[Asia Economy Reporter Cho Hyun-ui] Samsung Bioepis began selling the breast cancer treatment drug 'Ontruzant' in the United States on the 15th (local time). This comes 1 year and 3 months after receiving sales approval from the U.S. Food and Drug Administration (FDA) in January last year. With this, Samsung Bioepis's U.S. lineup has expanded to two products, including the autoimmune disease treatment drug 'Renflexis,' which was launched in July 2017.

Ontruzant is a biosimilar (biopharmaceutical copy) of 'Herceptin,' developed by Genentech and sold by the multinational pharmaceutical company Roche. It is a blockbuster drug used as an anticancer antibody treatment for early breast cancer, metastatic breast cancer, and metastatic gastric cancer, recording global sales of approximately 7.2 trillion KRW last year.

The U.S. sales of Ontruzant were delayed due to more than ten patent lawsuits filed by Genentech against Samsung Bioepis regarding treatment and manufacturing methods. Ultimately, the obstacle was removed when Samsung Bioepis settled the patent dispute with Genentech and signed a licensing agreement in July last year, six months after receiving sales approval.

With this launch, Samsung Bioepis can now participate in the Herceptin market in the U.S., which is worth about 3.2 trillion KRW. Sales and marketing in the U.S. will be handled by partner MSD (Merck & Co., Inc., USA). Ontruzant plans to enter the initial market at a price approximately 15% lower than the original drug's price. Before Ontruzant, only two Herceptin biosimilars had received U.S. sales approval: 'Ogivri,' jointly developed by Mylan in the U.S. and Biocon in India, and 'Herzuma' by Celltrion.

Samsung Bioepis plans to continue expanding its U.S. lineup. In addition to Renflexis and Ontruzant, it has obtained FDA sales approval for two autoimmune disease treatment biosimilars, 'Eticovo' and 'Hadlima.' In November last year, it applied for sales approval of 'SB8,' an anticancer drug used for metastatic colorectal cancer and non-small cell lung cancer.

Go Han-seung, President of Samsung Bioepis, said, "We are honored to introduce our first anticancer drug in the world's largest pharmaceutical market, the United States," and added, "We expect biosimilars to gain more attention in the U.S. market by improving accessibility to high-quality drugs at reasonable prices."

This content was produced with the assistance of AI translation services.