Blog Big Molecule Watch April 30, 2019

FDA Approves Second Etanercept Biosimilar

The U.S. FDA has approved ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL®, for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in patients aged 2 years or older, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in patients aged 4 years or older.  These are the same indications for which the reference product is approved.  According to a company press release, the approval is based on a 52-week Phase III clinical study involving patients with rheumatoid arthritis, in which it is reported that ETICOVO demonstrated comparable safety and efficacy to the reference product ENBREL®.  ETICOVO becomes the third biosimilar to receive FDA approval this year, and the nineteenth overall.

ETICOVO is just the second etanercept biosimilar to obtain FDA approval.  The first was Sandoz’s ERELZI (etanercept-szzs), which was approved in 2016, though its marketing has been delayed due to patent litigation that is currently awaiting a decision from the trial court.

ETICOVO is Samsung Bioepis’s third biosimilar (and second anti-TNF biosimilar) to receive FDA approval, following RENFLEXIS® (infliximab-abda) in 2017, and ONTRUZANT (trastuzumab-dttb) this past January.  The press release notes that ETICOVO is also approved in twenty-eight European Union states, three European Economic Area states, and in Switzerland, Canada, Brazil, Australia, New Zealand, Israel, and Korea.

 

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