Second Etanercept Biosimilar, ETICOVO, Wins FDA Approval

The Food and Drug Administration (FDA) approved a second biosimilar for etanercept (ENBREL, Amgen).

The latest approval is for ETICOVO (etanercept-ykro), manufactured by Samsung Bioepis. The tumor necrosis factor (TNF) blocker is indicated to treat rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA) in patients aged ≥ 2 years, psoriatic arthritis (PsA), ankylosing spondylitis (AS), and plaque psoriasis in patients aged ≥ 4 years.

“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,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis, 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.”

ETICOVO is administered via injection at a 50 mg dose once weekly in adult RA and PsA patients (with or without methotrexate [MTX]), adult AS patients, and pediatric PsO and JIA patients. Adult PsO patients are indicated to receive twice weekly doses for three months, followed by once weekly doses.

Trial Compares ETICOVO to Etanercept

The efficacy of ETICOVO compared to its reference drug was measured in a phase 3, randomized, double-blind, multi-center study, the results of which were published in the December 2017 issue of Rheumatology. The trial included patients with moderate to severe RA for whom MTX treatment was unsuccessful. Patients were randomized to receive 50 mg a week of either ETICOVO or etanercept for 52 weeks. The study’s primary outcome was the proportion of patients who achieved at least 20% ACR response criteria improvement (ACR20). Other outcomes included 28-joint Disease Activity Score (DAS28), Simplified and Clinical Disease Activity Indices (SDAI and CDAI), and changes in the modified total Sharp score (mTSS).

A total of 596 patients were included in the trial—299 in the ETICOVO cohort and 297 in the etanercept cohort. Mean overall age was 51.8 years, and most patients (86.4%) were aged younger than 65 years. The majority of patients (84.2%) were female. Mean disease duration was 6.1 years, and mean duration of MTX use was 47.7 months.

Overall, 505 (84.7%) patients completed the trial. After 52 weeks, the ACR20 response rates were 80.8% in the ETICOVO group and 81.5% in the etanercept group. Efficacy outcomes remained similar between the groups up to week 52. The groups presented similar radiographic progression. The change in mTSS from baseline was 0.45 in the ETICOVO group and 0.74 in the etanercept group. DAS28 improvement from baseline was a mean 2.91 for the ETICOVO group and 2.80 for the etanercept group. Mean improvements in SDAI were 28.7 and 27.7 for the ETICOVO and etanercept groups, and in CDAI were 27.9 and 26.8, respectively. The study also found similar safety profiles between the groups.