An employee works at Samsung Bioepis labs in Incheon, in this handout photograph taken on May 7, 2014 and provided by Samsung Bioepis. "We are confident we do not infringe on Janssen's patents," Samsung Bioepis spokesman Mingi Hyun said. J&J's Janssen unit sought a preliminary or permanent U.S. injunction to block the Bioepis version, arguing that it infringed three of its patents. Renflexis, which received U.S. approval in April, is the first medicine available in the United States under a global biosimilars agreement between Merck and Samsung Bioepis, a unit of Samsung BioLogics Co Ltd. Merck sells the branded version of Remicade outside the United States.
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Samsung Bioepis has advanced quickly since forming in 2012 as a joint venture between Samsung Biologics and Biogen (NASDAQ:BIIB). Samsung Bioepis boasts of 13 biosimilar candidates in total, including the six "first-wave" products listed above. Samsung Bioepis is still a private company, although there was speculation two years ago that it was planning to float on Nasdaq in the US for around $1bn. So far, Europe has been keener to embrace biosimilars, but this could change as pricing pressure in the US continues and biosimilars become more accepted. A separate licensing agreement, which gives Biogen European marketing rights for any anti-TNF biosimilars, remains in place.
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