Eticovo (etanercept-ykro), a biosimilar of Enbrel (etanercept), has been approved by the U.S. Food and Drug Administration (FDA) as a therapy for lessening symptoms in children ages two and older with polyarticular juvenile idiopathic arthritis (JIA).
The therapy, developed by Samsung Bioepis, also was approved by the FDA for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis.
Eticovo is a tumor necrosis factor (TNF) inhibitor that carries the same therapeutic activity, safety and quality — the characteristics of a biosimilar — as its reference medicine, Enbrel. Marketed by Amgen, Enbrel was the first TNF blocker approved for the treatment of polyarticular JIA.
The FDA’s decision was based on positive findings from a Phase 3 study (NCT01895309) that compared Eticovo’s safety and efficacy to that of Enbrel in patients with moderate-to-severe rheumatoid arthritis who had already received methotrexate therapy, currently the recommended first-line treatment.
During the study, done across 70 clinical sites in 10 countries, 596 patients with rheumatoid arthritis were randomly given a weekly 50 mg dose of Eticovo (delivered into the skin) or Enbrel for 52 weeks.
Eticovo showed comparable efficacy to Enbrel, as measured by the American College of Rheumatology 20 (ACR20) response rate at week 52 — 80.8% in Eticovo versus 81.5% in Enbrel. Comparable effectiveness had already been shown at 24 weeks, with ACR20 response rate of 78.1% in the Eticovo and 80.3% in the Enbrel group.
The biosimilar’s safety and tolerability profiles, as well as its potential to activate the immune system, also were found to be similar to those reported on prior studies with Enbrel.
The results from the 52-week trial were published in the journal Rheumatologyin a study titled, “52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis.”
Eticovo is Samsung Bioepis’ second anti-TNF biosimilar approved in the U.S.
“The approval of ETICOVO adds to our growing portfolio of anti-TNF medicines in the US, where we believe biosimilars can bring meaningful value to the country’s healthcare system,” Christopher Hansung Ko, president and CEO of Samsung Bioepis, said in a press release.
“Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry’s strongest biosimilar pipelines,” he added.
Eticovo has already been approved in 38 countries, including the 28 members of the European Union, and in Norway, Iceland and Liechtenstein, Switzerland, Canada, Brazil, Australia, New Zealand, Israel, and Korea.