Samsung Bioepis wins U.S. approval to sell biosimilar referencing Enbrel

Lim Chang-won Reporter() | Posted : April 26, 2019, 10:38 | Updated : April 26, 2019, 10:38

[Courtesy of Samsung Bioepis]

SEOUL -- Samsung Bioepis, a U.S. and South Korean joint venture company, has won U.S. approval to sell its biosimilar referencing Enbrel (etanercept), one of the best-selling pharmaceutical products, that treats chronic diseases, including moderate to severe rheumatoid arthritis.

Samsung Bioepis said Friday that the U.S. Food and Drug Administration (FDA) has approved its biosimilar developed as SB4, which has received regulatory approval as Benepali in Europe and Brenzys in South Korea, Australia and Canada.

SB4's release date in the U.S. market was not disclosed as Enbrel's U.S. patent expires in 2029. Enbrel marketed by Amgen and Pfizer has U.S. approval to treat rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Samsung Bioepsis, a joint venture between Biogen, a U.S.-based pharmaceutical company, and Samsung BioLogics, a bio company affiliated with South Korea's largest Samsung Group, has been known for Imraldi, an adalimumab biosimilar referencing Humira. Trastuzumab, sold under the brand name Herceptin, is a monoclonal antibody used to treat breast cancer developed by Swiss pharmaceutical giant Roche.

Samsung Bioepis has won U.S. approval to sell Ontruzant, a cancer-treating biosimilar referencing Herceptin. It was the company's first oncology biosimilar to receive FDA approval.
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