BMY Bristol Myers Squibb Co

SEOUL—The Samsung Group's drug-development arm said it is on track to win European regulatory approval for a knockoff version of Johnson & Johnson's blockbuster rheumatoid arthritis drug Remicade, marking a second straight victory for the South Korean conglomerate's fledgling ambitions in biologic drugs.

Samsung Bioepis Co., which the technology-focused conglomerate founded four years ago to develop near-replicas of existing biologic drugs, said in a statement that it received a positive opinion on its drug from the European Medicines Agency, clearing the way for European Commission approval.

Earlier this year, Samsung Bioepis won approval from the European Commission for its near-replica of Enbrel, another top-selling rheumatoid arthritis drug.

Samsung Bioepis started selling selling its near-replica of Enbrel under the Benepali name in Europe this year, in partnership with Biogen Inc., at a steep discount to the original drug's price. Enbrel's patent expired in Europe in August. In Norway, where the government sets drug prices at public hospitals, Benepali sells for about half the price of Enbrel.

Remicade and Pfizer Inc.'s Enbrel each generate about $9 billion in revenue a year, making them two of the five best-selling biologic drugs in the world.

In addition to these two drugs, Samsung Bioepis has finished Phase 3 clinical trials of a near-replica of AbbVie Inc.'s Humira, the world's top-selling prescription drug last year, which had $14 billion in global sales.

Unlike simpler, chemically synthesized drugs like 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 chemically synthesized drugs, offering similar treatments at lower prices.

Samsung's third-generation heir apparent, Lee Jae-yong, has looked to the biologic drug industry as a growth engine as profit growth at smartphone maker Samsung Electronics Co. has slowed.

Samsung's efforts in the biologic industry have two tracks. One company, Samsung BioLogics Co., is aiming to become the world's largest contract manufacturer of biologic drugs developed by companies such as Bristol-Myers Squibb Co. and Roche Holding AG.

Meanwhile, subsidiary Samsung Bioepis is developing its own biosimilars of existing drugs whose patents have expired or will expire soon.

Last year, Samsung Bioepis said it was considering a listing on the Nasdaq Stock Market in the first half of 2016. Earlier this year, during a period of global market volatility, it issued a statement saying it was "evaluating U.S. market conditions to determine the optimal timing" for the listing. It didn't elaborate.

Samsung Bioepis' crosstown rival, Celltrion Inc., won European regulatory approval for its near-replica of Remicade three years ago. In February, Celltrion's Remicade biosimilar was recommended for approval by an advisory panel of the U.S. Food and Drug Administration.

The global biologic drug market will top $390 billion by 2020, accounting for nearly a third of the global pharmaceutical market by value, according to a report last month by the IMS Institute for Healthcare Informations.

Write to Jonathan Cheng at jonathan.cheng@wsj.com

(END) Dow Jones Newswires

April 01, 2016 12:15 ET (16:15 GMT)

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