Samsung Gets European Approval for Enbrel Copy

SEOUL—Samsung Group said it has won approval from regulators to sell a near-replica of the blockbuster rheumatoid arthritis drug Enbrel in Europe, marking an early milestone for South Korea's biggest conglomerate in the nascent market for so-called biosimilar drugs.

The approval comes as Samsung Bioepis Co., the conglomerate's drug development arm, is preparing a public listing on the Nasdaq Stock Market.

Samsung's third-generation heir apparent Lee Jae-yong has looked to the biologic drug industry as a growth engine amid slowing profit increases at its lucrative flagship company, smartphone maker Samsung Electronics Co.

Unlike simpler, chemically-synthesized drugs such as aspirin, biologic drugs are made from living cells to treat a variety of ailments ranging from cancer to arthritis. Biosimilars are near-replicas of biologic drugs that are akin to the generic versions of chemical drugs, offering similar treatments at lower prices.

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 biologic drugs developed by companies such as Bristol-Myers Squibb Co. and Roche Holding AG.

Meanwhile, its subsidiary Samsung Bioepis, which was founded four years ago, is developing its own biosimilars of existing drugs whose patents have expired or will expire soon, including Pfizer Inc.'s Enbrel and Johnson & Johnson's Remicade.

The greenlighting of the biosimilar by the European Commission, which oversees drug approvals for the European Union, is Samsung Bioepis's first in a major market. Samsung Bioepis has a deal with Cambridge, Mass.-based Biogen Inc. to commercialize and distribute the Samsung biosimilar in Europe, where it will be marketed under the name Benepali.

Samsung Bioepis also is planning to seek regulatory approval for the biosimilar from the U.S. Food and Drug Administration. The biosimilar won approval from South Korean regulators and went on sale last year in partnership with MSD Korea Ltd., a subsidiary of Merck & Co., where it is sold as Brenzys.

Biosimilars are still a burgeoning field, with regulators moving more cautiously than some analysts had expected in approving them, particularly in the U.S.

In addition to the Enbrel biosimilar, Samsung Bioepis has five other biosimilars in development, and the company's chief executive officer Christopher Ko said in a statement that it would file for regulatory approval of "a number of them" in markets around the world in the coming months.

Just down the street from Samsung Bioepis' headquarters in Songdo, South Korea, rival Celltrion Inc. won EMA approval in 2013 for Remsima, its near-replica of the blockbuster rheumatoid arthritis drug Remicade. The company is seeking FDA approval for Remsima, and submitted an application last year to the EMA for a biosimilar of Roche's cancer treatment Rituxan.

Write to Jonathan Cheng at [e-mail]

Corrections & Amplifications: Samsung Bioepis' biosimilar was approved by the European Commission. An earlier version of this article incorrectly stated it was approved by the European Medicines Agency. (Jan. 17)

(END) Dow Jones Newswires

January 17, 2016 21:15 ET (02:15 GMT)

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