Samsung Bioepis Co., a biotechnology research and development unit of South Korea’s largest conglomerate Samsung Group, said on Monday it has filed with the European Medicines Agency (EMA) for marketing approval of its third biosimilar SB5 in Europe after it got the greenlight to sell its first two biosimilar drugs - Benepali and Flixaby in the region.

Samsung Bioepis said it submitted a new drug application (NDA) to the EMA for SB5 in May and the EMA recently notified that it began a full-scale review. SB5 is a biosimilar version of Humira, U.S-based AbbVie Inc.’s blockbuster rheumatoid arthritis drug whose sales hit about 16 trillion won ($14.05 billion) last year.

Samsung already received marketing approval of its two other biosimilar drugs - Benepali and Flixaby in the region. If SB5 is approved, Samsung Bioepis will have three products in its line-up for the European market that can be alternatives to the world’s three best-selling anti-TNF alpha agents - AbbVie’s Humira, Janssen’s Remicade and Amgen’s Enbrel - among autoimmune disease treatments, said company chief executive Ko Han-seung. These three original drugs generated about 34 trillion won in sales in 2015.

Samsung’s NDA is based on data of a phase 3 study of 544 RA patients at 52 hospitals in seven countries that showed comparability with the original drug in efficacy and safety. The data was presented in the American College of Rheumatology (ACR) meeting of 2015.

In a study of switching to copycat SB5 from the original drug at 24 weeks through 52 weeks, data also demonstrated efficacy, safety and immunogenicity similar to Humira, which was presented to the EULAR Congress in 2016.

Samsung Bioepis is now conducting a phase 3 study of SB3, a biosimilar version of Herceptin, and SB8, a copycat of Avastin. The company’s SB9, a biosimilar version of Lantus, is being reviewed by the EMA.

By Shin Chan-ok

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