Samsung Bioepis Co. announced its biosimilar drug Renflexis (infliximab) to treat autoimmune disease was approved by the U.S. Food and Drug Administration (FDA) last Friday (local). The approval came about 13 months after it applied for NDA review in March last year, but still earlier than expected given the regulator’s strict approval processes.

Renflexis is a biosimilar version of Johnson & Johnson’s Remicade, an antibody used to treat rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis and psoriasis. Remicade is a blockbuster drug with worldwide sales of 9.3 trillion won ($8.22 billion) last year.

Renflexis was approved in Korea in 2015 and in Europe and Australia in 2016. In Europe, the drug is available under the brand name of Flixabi.

The FDA’s approval further gave credential to Samsung’s five-year-old biosimilar developer. Samsung’s U.S. partner Merck & Co. will be responsible for marketing of Renflexis in the world’s largest pharmaceutical market. Renflexis will pit against Remsima launched late last year developed by its local rival Celltrion. They have the same reference drug Remicade.

Currently, five biosimilars have been approved in the U.S. Two of them are launched by the two Korean makers.

Remsima, the world’s first copy drug, was launched in Europe in 2015 and its market share there stands at over 40 percent, and Celltrion is active in promoting the drug in the American market in cooperation with Pfizer. Samsung Bioepis is a latecomer biosimilar developer but has been making fast ascension in the global market, backed by Samsung Group’s rich funding.

Renflexis is likely to be available in the U.S. from late this year or early this year after a legally-mandated notice period of six months. “The U.S. approval represents a milestone achievement made in five years after the founding of Samsung Bioepis. With the approval, patients with autoimmune disease will have more treatment opportunities in the U.S.,” said Ko Hansung, chief executive of Samsung Bioepis..

Shares of Samsung BioLogics, a contract drug producer that nearly wholly-owns Samsung Bioepics, ended Monday down 2.1 percent from previous session at 183,000 won.

By Shin Chan-oak

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]