26 April 2019 - The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro).
The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). Before the FDA announced this development, a representative from Samsung Bioepis confirmed approval of the product to The Center for Biosimilars® in an email.
The biosimilar was approved to treat all indications of its reference, Enbrel: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.