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Samsung Bioepis wins FDA approval for biosimilar

All Headlines 10:56 April 26, 2019

By Kim Han-joo

SEOUL, April 26 (Yonhap) -- South Korean pharmaceutical firm Samsung Bioepis Co. said Friday it has won approval from the U.S. Food and Drug Administration to sell one of its biosimilar in the United States.

Etanercept -- a biosimilar referencing the immunology drug Enbrel developed by U.S.-based Amgen Inc. -- will be used in the treatment of rheumatoid arthritis and psoriatic arthritis, the company said in a press release.

However, it is undecided yet when Etanercept will go on sale in the U.S. as the patent for Enbrel is to expire in 2029. Biosimilars are officially approved as copycat medicines only after the patents for the original biopharmaceuticals expire.

It is the third Samsung Bioepis biosimilar to receive the green light from the FDA. It is already selling Renflexis -- a biosimilar of Janssen Biotech, Inc.'s blockbuster immunology medicine Remicade -- and Ontruzant -- a biosimilar product referencing Switzerland-based Roche Holding's Herceptin, also known as Trastuzumab -- in the U.S.

"Our R&D capabilities were once again affirmed in the U.S., the world's largest biopharmaceutical market, by getting the approval for the third product," Samsung Bioepis CEO Christopher Hansung Ko said in a press release. He further expressed hope that the products play an important role in widening patient access to high-quality health care at reasonable price.

Samsung Bioepis -- a joint venture between Samsung BioLogics and Biogen Inc. -- is already selling Etanercept in Euorpe under the name of Benepali, following approval in 2016. Samsung BioLogics is a biopharmaceutical unit of South Korea's top conglomerate, Samsung Group.

Biosimilars are defined by the FDA as products that are "highly similar to an already approved biological product," which has "no clinically meaningful differences in terms of safety and effectiveness from the reference product."

This undated photo provided by South Korean pharmaceutical firm Samsung Bioepis Co. shows its headquarters building in Songdo, west of Seoul. (Yonhap)


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