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.