FDA approves Samsung Bioepis' copy of J&J's Remicade: company

South Korea's Samsung Bioepis Co Ltd said on Saturday the U.S. Food and Drug Administration approved its copy of Johnson & Johnson's rheumatoid arthritis drug Remicade, the first drug developed by the Samsung Group unit approved in the United States.

The drug, called Renflexis, is a biosimilar – a copy of a biotech drug - and the second Remicade copy to be approved in the world's largest pharmaceutical market. Remicade is J&J's biggest selling drug with U.S. sales of about $5 billion a year.

Established in 2012 as a relative latecomer to the industry, Samsung Bioepis has found early success by beating rivals to market on biosimilars of some of the world's top-selling drugs by so far investing $1.3 billion into biosimilar development.

It became the first company to launch a biosimilar version of Amgen's Enbrel, another rheumatoid arthritis drug, in Europe. It also submitted for approval its copy of Roche's blockbuster breast

cancer drug Herceptin and its copy of AbbVie Inc's rheumatoid arthritis drug Humira, both in Europe.

Renflexis will be marketed and distributed in the United States by Merck & Co Inc, Samsung Bioepis said in a statement. It received European approval in May 2016.

The FDA approved the drug a little more than a year after the first Remicade biosimilar copy - Pfizer's Inflectra, developed by South Korea's Celltrion – was approved. Inflectra was introduced in the U.S. in late 2016.

Remicade accounted for about 9.7 percent of Johnson & Johnson's total revenues for fiscal 2016, and biosimilar competition is expected to reduce U.S. sales, J&J said in its annual report.

(Corrects Bioepis' Herceptin copy was submitted for approval, not approved, in paragraph 4)

(Reporting by Joyce Lee; Editing by Grant McCool)

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