Samsung Targets U.S. Drug Market With Remicade Knockoff
May 23 2016 - 4:40PM
Dow Jones News
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.
(END) Dow Jones Newswires
May 23, 2016 16:25 ET (20:25 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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