Samsung Bioepis said on April 25 (local time) that it has received final approval from the U.S. Food and Drug Administration (FDA) to sell its Enbrel biosimilar Eticovo (ingredient name: etanercept).
Eticovo is the company’s third biosimilar product approved in the United States, following Renflexis (ingredient name: infliximab) and Ontruzant (ingredient name: trastuzumab).
Eticovo is a biosimilar for Enbrel, an autoimmune disease treatment developed by Amgen of the U.S. Enbrel is a blockbuster biologic medicine that recorded about 8.13 trillion won (US$ 7.01 billion) in global sales last year. U.S. sales amounted to about 5.48 trillion won, or about 67 percent of global sales.
Like the original medicine, Eticovo can be prescribed as a treatment for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis. The release date and the vendor have not been decided.
Eticovo was launched in Europe in 2016 under the product name Benepali and is currently being sold through Biogen, the marketing partner of Samsung Bioepis. Benepali has surpassed 1 trillion won (US$862 million) in cumulative sales just three years after its release due to the first mover effect and its user convenience.
"We have received a global recognition of our R&D capability by winning U.S. approval on our third product," said Koh Han-seung, president of Samsung Bioepis. "We will try to enable more patients to use high-quality bio-medicine at reasonable prices."