24 May 2016 - Affiliate Samsung Bioepis says its biosimilar of the arthritis drug is being reviewed by the FDA.

Samsung Group said Tuesday its near-replica of Johnson & Johnson’s blockbuster arthritis drug Remicade has been accepted for review by the U.S. FDA, marking the South Korean conglomerate’s first attempt to sell drugs to Americans, alongside its popular smartphones and televisions.

Samsung Bioepis Co., a Samsung affiliate that develops biosimilars, or near-replicas of biologic drugs that are made from living cells, has already won preliminary regulatory approval for its Remicade copy from the European Medicines Agency. It began selling a biosimilar of Pfizer Inc.’s rheumatoid arthritis drug Enbrel this year in Europe.

But the Remicade application with the FDA is Samsung’s first foray into the world’s largest drug market, where lawmakers and the FDA have only recently created a legal opening for biosimilars. Biosimilars are akin to generic versions of chemically synthesized drugs offering similar treatments at lower prices.

For more details, go to: http://www.wsj.com/articles/samsung-targets-u-s-drug-market-with-remicade-knockoff-1464033605