Samsung Makes Big Play in Drug Market With Cheaper Version of Blockbuster Humira
June 23 2017 - 8:02AM
Dow Jones News
By Timothy W. Martin in Seoul and Jonathan D. Rockoff in New York
A Samsung group arm is on track to win European regulatory
approval for a near-replica version of the world's top-selling
drug, AbbVie Inc.'s rheumatoid-arthritis treatment Humira, the
latest achievement by the deep-pocketed South Korean conglomerate
attempting to shake up the pharmaceutical market.
Samsung Bioepis Co., the group's new biotechnology company, said
in a statement Friday that it had received a positive opinion from
the European Medicines Agency for its treatment, known as Imraldi.
That decision clears the way for approval from the European
Commission, whose judgment typically mirrors that of the EMA.
If it gets the green light, Imraldi would represent the third
Samsung-developed medication to win government approval in Europe
and the U.S--an unusually fast start for a five-year-old company,
industry analysts say. All three Samsung treatments are close
imitations of rheumatoid-arthritis drugs that rank among the
world's biggest sellers.
In April, Samsung's version of Johnson & Johnson's Remicade
won U.S. Food and Drug Administration approval to begin sales later
this year. In Europe, Samsung has sold the Remicade near-replica
and its version of Pfizer Inc.'s Enbrel since last year.
Biologic drugs, such as Humira or Remicade, are made out of
living cells and treat complex diseases including cancer or
arthritis. Annual treatments can total tens of thousands of dollars
a year--if not more, making them one of the most lucrative segments
of the drug industry.
However, with patent protections expiring, Samsung and other new
players have been working to produce lower-priced near-replicas of
biologic drugs, akin to the generic versions of chemically
synthesized drugs like aspirin. Efforts to sell--or block--these
biosimilar treatments have led to a flood of lawsuits in the U.S.
and Europe.
In this world, Samsung, an empire accounting for nearly
one-third of South Korea's stock-market value, ranks as an unusual
player: a well-resourced competitor whose fortunes aren't solely
tethered to global health spending but spread across other
industries from consumer electronics to construction.
Samsung's Imraldi treatment, if approved by the European
Commission, would be the second near-replica of Humira to receive
regulatory backing, after Amgen Inc.'s version was approved in the
U.S. and Europe in September 2016 and March 2017, respectively.
Humira, which is also used to treat other autoimmune diseases
and is administered through injections, racked up more than $16
billion in global sales last year. A year's supply of Humira has a
retail price of more than $50,000 in the U.S., with the costs
varying by country in Europe.
Christopher Ko, Samsung Bioepis's chief executive, said in a
statement that the EMA's decision "brings us a step closer to
delivering a lower-cost, high-quality autoimmune treatment option
to patients."
Industry analysts expect Samsung, Amgen and other drugmakers
will be able to roll out Humira biosimilars in Europe after
AbbVie's main patent on the drug there expires in October 2018.
Samsung, Amgen and other drugmakers will be able to roll out
Humira biosimilars in Europe after AbbVie's main patent on the drug
there expires in October 2018.
In an echo of Samsung's earlier shift to focus on semiconductors
and smartphones, the conglomerate has recently begun to embrace
complex medicines as a potential source of growth.
In addition to Samsung Bioepis's development of biosimilars of
drugs whose patents are set to soon expire, another new Samsung
affiliate, Samsung BioLogics Co., is investing heavily to become
the world's largest contract manufacturer of biologic drugs.
Write to Timothy W. Martin at timothy.martin@wsj.com and
Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com
(END) Dow Jones Newswires
June 23, 2017 07:47 ET (11:47 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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