Samsung Bioepis Also Faces 2029 Wait For US Etanercept Biosimilar

New Jersey Court Enters Permanent Injunction Against Korean Firm

Samsung Bioepis’ etanercept biosimilar, freely available in Europe, will not be sold in the US until patent expiry in 2029 following action by a US district court.

Amgen
Amgen has now overseen victories against two biosimilar sponsors • Source: Alamy

Samsung Bioepis has joined Sandoz in being unable to offer its biosimilar etanercept product in the US until 2029 after a New Jersey district court entered a final judgment and order of permanent injunction against the firm pertaining to two US patents covering Amgen’s Enbrel (etanercept) anti-TNF original.

The Korean-based joint venture between Samsung BioLogics and Biogen has held US Food and Drug Administration approval for its Eticovo (etanercept-ykro) biosimilar since April 2019 but has been unable to launch due to intellectual property hurdles

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