Autoimmune diseases

FDA Approves Enbrel Biosimilar

The US Food and Drug Administration (FDA) has approved Eticovo (etanercept-ykro), an etanercept (Enbrel) biosimilar. The biosimilar is approved to treat all referent conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.


The safety and efficacy of etanercept-ykro was similar to that of the reference product. It is administered as a single-dose 50 mg/mL prefilled syringe.


The most common adverse events associated with use of etanercept-ykro include infections and injection site reactions.