South Korea's Samsung Bioepis won European Commission approval for commercial sales of a biosimilar of Amgen's ($AMGN) Enbrel, marking a first that will make its version of the rheumatoid arthritis treatment available across the European Union as well as in Norway, Iceland and Liechtenstein.
The product, named Benepali for the European market, will be commercialized by partner Biogen ($BIIB), the company said in a statement last week
"The EC approval follows a positive opinion on Benepali by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), which was announced on Nov. 20, 2015," Incheon-based Samsung said in a release.
Last week, the Canadian unit of U.S.-based Amgen filed a lawsuit against Samsung Bioepis over patents for Enbrel for the version up for offer there called Brenzys.
Brenzys, also known as SB4, was approved in December 2015 in South Korea and is being sold by MSD Korea, a unit of Merck ($MRK).
The venture plans to list on the Nasdaq in an initial public offering that could raise more than $1 billion to expand its biosimilar push.
In addition to its Enbrel biosimilar, the company is close to gaining approval of its biosimilars for Johnson & Johnson's ($JNJ) Remicade, Roche's ($RHHBY) Herceptin and AbbVie's ($ABBV) Humira. The company also has a Phase I clinical trial underway for a biosimilar of Avastin, according to its website.
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| Samsung Bioepis CEO Christopher Ko |
"The approval of Benepali and its subsequent launches in Europe are major milestones for Samsung Bioepis," Christopher Ko, president and CEO of Samsung Bioepis, said in a statement.
"In addition to Benepali, we continue to advance one of the industry's broadest biosimilar pipelines with multiple biosimilar candidates in Phase III clinical trials. Over the coming months, a number of them will be filed for regulatory approval in markets across the world."
- here's the release