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 NDAQ -0.08 % in the first half of 2016 remains on ice, halted amid market volatility at the beginning of the year.
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 FDA has approved only two biosimilars so far, including a knockoff of Remicade developed by Celltrion Inc., 068270 0.21 % whose headquarters in Incheon, South Korea is a short walk from Samsung Bioepis s offices.
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 Corp. 028260 0.42 % 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.