Medication Monitor

Generic Name (Trade Name—Company)
May 1, 2019


(Eticovo—Samsung Bioepis)
Biosimilar to etanercept gains FDA approval

Samsung Bioepis announced FDA approval of etanercept-ykro, a biosimilar of etanercept (Enbrel). The drug is a tumor necrosis factor blocker indicated for treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis. 

Approval was based on a 52-week Phase III clinical study that randomized 596 patients with rheumatoid arthritis across 70 sites in 10 countries. The biosimilar demonstrated comparable safety and efficacy to the etanercept reference product, Enbrel.

The labeling includes a warning that patients treated with etanercept products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. The drug's risks and benefits should be carefully considered before initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection before therapy initiation. Etanercept-ykro should be discontinued if a patient develops a serious infection or sepsis.