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Samsung Bioepis’ Etanercept Nod Prompts US Lawsuit

 
• By Penelope MacRae and Aidan Fry
  
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The FDA has approved Samsung Bioepis’ Eticovo as the second biosimilar competitor to Amgen’s blockbuster rheumatoid arthritis biologic Enbrel. Amgen immediately sued for patent infringement.

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Samsung Bioepis Has Received The Second US Nod For Biosimilar Etanercept • Source: Shutterstock

Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, has won US Food and Drug Administration approval for Eticovo (etanercept-ykro), the second approved US biosimilar rival to Amgen’s Enbrel. The originator immediately sued for patent infringement in a bid to protect its best-selling brand, which generated $4.81bn of its $5.01bn total turnover last year in the US. Samsung Bioepis has not announced a US launch date for the tumor necrosis factor (TNF) inhibitor.

In the suit brought in a New Jersey district court by Amgen and its partner Roche on 29 April,...

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