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.
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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.
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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.
Biolgics had $202 billion in world-wide sales last year, and the drugs are expected to have $214 billion in sales this year, according to EvaluatePharma, a source of pharmaceutical market data and analysis. It estimates sales will reach $276 billion world-wide in 2020.
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 email@example.com and Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com
(END) Dow Jones Newswires
June 23, 2017 10:33 ET (14:33 GMT)