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Samsung Bioepis files for marketing approval for SB3 in Korea

Collected: 2016.09.20

Distributed: 2016.09.21

Source: Go Direct

Samsung Bioepis Co., a biotechnology research and development unit of South Korea’s largest conglomerate Samsung Group, last Tuesday filed with the Ministry of Food and Drug Safety (MFDS) for marketing approval of its first cancer treatment biosimilar SB3, according to sources from the industry on Monday.

If Samsung Bioepis is granted with marketing approval for SB3, a biosimilar of blockbuster breast cancer drug Herceptin, it would be able to sell its first-ever biosimilar for cancer treatment. The company, which has a pipeline of six biosimilar drugs, has already launched two autoimmune disease drugs - Benapali and Flixaby - in Korea and Europe, but not for cancer treatment biosimilar drugs.

Another Korean biotechnology company Celltrion Inc. has already got a nod from the Korean authority in 2014 to sell its own biosimilar of Herceptin under the name of mAb Herzuma, but it failed to catch on the market.

To bolster sales of SB3, Samsung Bioepis plans to wage aggressive marketing campaign through MSD Korea, the local affiliate of U.S.-based pharmaceutical company Merck & Co, once it wins a green light from the MFDS. Breast cancer drugs command much larger market share than do rheumatoid arthritis drugs. Herceptin, sold by Roche Korea Co., is estimated to have sold more than 100 billion ($89.4 million) won a year in Korea and raised $6.8 billion in global sales last year.

By Lee Dong-in

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