Aju Business Daily

SEOUL -- Samsung Bioepis, a U.S. and South Korean biopharmaceutical joint venture company, promised to seek a license for the marketing of SB11, a biosimilar candidate referencing Lucentis (ranibizumab), in the United States and Europe saying its efficacy has been demonstrated through final-stage clinical trials.

Ranibizumab, developed by Genentech and marketed by Novartis under the brand name Lucentis, is an anti-angiogenic that has been approved to treat the "wet" type of age-related macular degeneration, a common form of age-related vision loss.

From March 2018 to December 2019, Samsung Bioepis conducted clinical trials on 705 patients with neovascular age-related macular degeneration to compare and study clinical efficacy between SB11 and original medicines. The company said clinical equivalence with original medicines has been demonstrated.

Samsung Bioepis, 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, said it would apply for a license for SB11's sales in the U.S. and Europe as early as the end of this year. 

"Our first eye disease treatment is expected to provide excellent treatment benefits to patients," an unnamed Samsung Bioepis official was quoted as saying. SB11 is the company's sixth biosimilar and first ophthalmic disease treatment.

Samsung Bioepis has entered into a new commercialization agreement with Biogen for two biosimilar candidates, SB11 and SB15, in the U.S., Canada, Europe, Japan, and Australia. SB15, a biosimilar candidate referencing Eylea (aflibercept), is in pre-clinical development.

Samsung Bioepsis has been known for Imraldi, an adalimumab biosimilar referencing Humira. In 2019, the company 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.