The 4th Biosimilar Rolled out in Europe

Samsung Bioepis has launched “Imraldi,” a biosimilar to Humira, the world's top-selling biopharmaceutical, in Europe.

Samsung Bioepis has launched “Imraldi,” a biosimilar to Humira, the world's top-selling biopharmaceutical from AbbVie, in Europe.

Samsung Biotepis CEO Han Seung-jin said on Oct. 17, "With the launch of Imraldi, Samsung Bioepis has successfully rolled out all of its four biosimilars that have been approved in Europe. As a leader in the biosimilar industry, we will try to provide patients with high-quality biopharmaceutical treatments at reasonable prices."

Humira is an autoimmune disease (anti-TNF-α) treatment developed by an American company Abbvie. The global sales of the blockbuster drug amounted to about US$18.427 billion in 2017. Its sales in the U.S. reached US$12.36 billion (about 13.6 trillion won), accounting for about 67% of its total sales. Sales in Europe have not been officially reported, but according to industry analysts, it is estimated to be about 5 trillion won (US$4.5 billion).

Samsung Bioepis received final sales approval for Imraldi in Europe in August last year. The new launch was made possible as the company signed a licensing contract with Abbvie in April after settling a patent dispute between the two.

Imralid can be used for treatment of rheumatoid arthritis, psoriasis, Crohn's disease, ulcerative colitis, and more. It will be sequentially launched in major countries, including Britain, France, Germany, Spain and Italy, followed by other European countries. The sales will be handled by Samsung’s marketing partner, Biogen.

Imaldi is the fourth biosimilar launched by Samsung Bioepis in the European market. The company launched Benepali (SB4, Enbrel biosimilar) and Flixabi (SB2, Remicade biosimilar) in 2016 and Ontruzant (SB3, Herceptin biosimilar) in 2018.

Earlier, three scientists, including Professor George Smith at University of Missouri, USA, who discovered enzymes that have functions useful to human and antibody production methods and contributed to the development of Humira, won the Nobel Prize in Chemistry and received attention from the industry.

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