FDA Approves Etanercept Biosimilar for Arthritis Indications

The US Food and Drug Administration (FDA) has approved an etanercept (ENBREL) biosimilar for the treatment of all its available indications, including 3 forms of arthritis.

The etanercept-ykro (ETICOVO) biosimilar, from Samsung Bioepis Co., was approved for the treatment of rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, and plaque psoriasis. It is now the company’s second anti-tumor necrosis factor (TNF) biosimilar approved for US marketing.

The biosimilar’s approval was supported by the results of a 52-week phase 3 clinical trial, during which 596 patients with rheumatoid arthritis across 10 countries were randomized to either the biosimilar or ENBREL. Investigators reported that 80.8% of patients administered the former reached the composite mark of American College of Rheumatology-graded improvement of at least 20% (ACR20); 81.5% of patients administered the latter achieved ACR20.

The findings confirmed 24-week study results showing a similar rate of ACR20 success in biosimilar- (78.1%) and brand- (80.3%) treated patients.

Etanercept products are associated with an increased risk of serious infections—particularly in patients taking concomitant immunosuppressants—that can lead to hospitalization or death. Infections could include active tuberculosis, invasive fungal infections, and both bacterial and viral infections.

Christopher Hansung Ko, president and chief executive officer of Samsung Bioepis, said he believes that biosimilars have a meaningful role of value to play in the US healthcare system—and that ETICOVO only adds to that portfolio.

“Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipeline," he said in a statement.