By Jonathan Cheng
SEOUL--Samsung Group said Tuesday its near-replica of Johnson & Johnson's blockbuster arthritis drug Remicade has been accepted for review by the U.S. Food and Drug Administration, 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.
While Samsung is better known for its consumer electronics, the conglomerate has plowed billions of dollars into the biologic drug industry in the past five years, betting that growth in the field for complex drugs will help it offset a slowdown in Samsung's mainstay businesses such as smartphones and semiconductors.
Samsung Bioepis's FDA application comes as the company's planned initial public offering on the Nasdaq Stock Market in the first half of 2016 remains on ice, halted amid market volatility at the beginning of the year.
Samsung's efforts in the biologic industry are two-pronged. One company, Samsung BioLogics Co., is aiming to become the world's biggest contract manufacturer of original biologic drugs, developed by companies such as Bristol-Myers Squibb Co. and Roche Holding AG.
Meanwhile, its subsidiary Samsung Bioepis is developing its own biosimilars of existing drugs whose patents have expired or will expire soon, including Enbrel and Remicade.
The company has 13 biosimilars in its pipeline, and marketing and distribution deals with pharmaceutical giants like Biogen Inc. and Merck & Co., which is licensed to sell Samsung's Remicade biosimilar in the U.S., after it is approved.
The FDA has approved only two biosimilars so far, including a knockoff of Remicade developed by Celltrion Inc., whose headquarters in Incheon, South Korea is a short walk from Samsung Bioepis's offices. Celltrion's biosimilar, called Inflectra, was approved last month by the FDA, and is licensed to Pfizer.
Last year, the FDA approved Novartis AG's biosimilar of Amgen Inc.'s Neupogen, a drug for cancer-chemotherapy patients, in a first for the U.S.
In all, the FDA received seven biosimilar drug applications as of September last year, according to a February report commissioned by the regulatory body.
Samsung Bioepis is 91.2% owned by Samsung BioLogics, which is in turned 47% owned by Samsung Electronics Co. and 51% owned by the conglomerate's de facto holding company Samsung C&T Corp. Earlier this month, Samsung BioLogics filed an application for an initial public offering on South Korea's main stock exchange, which analysts say could raise billions of dollars.