Sandoz’s Enbrel Biosimilar Filing May Spur New Litigation

Etanercept biosimilar could face more complications on both patent and review front than Zarxio experienced.

Sandoz Inc. is on track to get its second biosimilar approval in the US in June 2016 following FDA’s acceptance of its application for a biosimilar to Amgen Inc.’s rheumatoid arthritis and psoriasis drug Enbrel (etanercept).

But it could face a long delay to market unless it gets around Amgen's patents (the last of which expires in 2029) or opts to launch at risk.

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