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Bioepis gets green light from FDA

Apr 27,2019
Samsung Bioepis said Friday that its biosimilar used to treat some forms of arthritis has been approved by the U.S. Food and Drug Administration (FDA).

Etanercept, a biosimilar to immunology drug Enbrel developed by Amgen, will be used to treat rheumatoid arthritis and psoriatic arthritis, the pharmaceutical company said in a statement.

Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.

Enbrel made $7.13 billion in sales worldwide last year, with 67 percent, or $4.8 billion, of total sales in the United States.

But Bioepis has not decided when Etanercept will start commercialization in the United States, as the patent for the original drug Enbrel expires in 2029.

Biosimilars can go on sale only after the patents for original biopharmaceuticals expire.

“Our research and development capability was once again recognized in the United States, the world’s largest biopharmaceutical market, by getting the approval for a third product,” said Samsung Bioepis CEO Ko Han-sung in a statement.

Etanercept is the third biosimilar from Bioepis to earn FDA approval. Bioepis is already selling Renflexis, a biosimilar to immunology medicine Remicade from Janssen Biotech, and Ontruzant, a biosimilar referencing Switzerland-based Roche Holding’s Herceptin, in the United States.

Bioepis, a joint venture of Samsung BioLogics and Biogen, has already started selling Etanercept in Europe under the name of Benepali after receiving approval three years ago.

BioLogics is being investigated for breaking accounting rules to inflate the value of its subsidiary Bioepis ahead of BioLogic’s initial public offering in 2016. The Financial Services Commission reported that the alleged fraudulent accounting could amount to 4.5 trillion won ($3.8 billion).


BY KO JUN-TAE [ko.juntae@joongang.co.kr]