FDA approves Samsung Bioepis' etanercept biosimilar, Eticovo

Center for Biosimilars

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.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Biosimilar