Etanercept Biosimilar Approved to Treat Variety of Autoimmune Diseases

Phase 3 Study Confirmed Drug’s Comparable Safety and Efficacy

The FDA has approved etanercept-ykro (Eticovo™, Samsung Bioepis Co., Ltd.), a tumor necrosis factor (TNF) blocker and etanercept biosimilar, across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis.

In a 52-week randomized, double-blind, parallel group, multicenter clinical study (NCT01895309), which involved 596 adults aged 18 to 75 years old with rheumatoid arthritis, etanercept-ykro demonstrated comparable safety and efficacy to etanercept (Enbrel, Amgen), as evidenced in the ACR20 response rate of 80.8% in the etanercept-ykro arm versus 81.5% in the etanercept arm.

Patients treated with products containing etanercept are at increased risk for serious infections that may lead to hospitalization or death. Most patients who developed infections were taking concomitant immunosuppressants. Reported infections include:

  • Active tuberculosis, including reactivation of latent tuberculosis;
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis; and
  • Bacterial, viral, and other infections due to opportunistic pathogens such as Legionella and Listeria.

Lymphoma and other malignancies have been reported in children and adolescent patients treated with TNF blockers, including etanercept products.

In addition to its U.S. approval, etanercept has been approved for marketing in the European Union, Norway, Iceland, Liechtenstein, Switzerland, Canada, Brazil, Australia, New Zealand, Israel, and Korea.

Source: Samsung Bioepis, April 29, 2019