Samil Pharmaceutical said on Wednesday that it launched Samsung Bioepis’ Amelivu (ingredient: Ranibizumab), a Lucentis biosimilar to treat macular degeneration, in Korea.
Both companies had signed a domestic distribution and sales contract for Amelivu in June 2022. Amelivu is an ophthalmic disease treatment biosimilar of the original drug, Lucentis, that is effective in treating neovascular degeneration and vision damage caused by diabetic macular edema.
From March 2018 to December 2019, Samsung Bioepis conducted a phase 3 clinical trial of Amelivu in 705 patients with neovascular age-related macular degeneration (nAMD) in nine countries, and measured changes in best corrected visual acuity (BCVA) and central subfield thickness (CST) at 8 weeks after prescription as primary endpoints and confirmed the equivalence of efficacy, safety, and immunogenicity between the original drug and its biosimilar.
SB11, the project name for Amelivu, has obtained permission to sell in the U.S., Europe, Canada, and Korea, as the sixth biosimilar product developed and commercialized by Samsung Bioepis. Samsung Bioepis and Biogen launched SB11 in the U.S. in June last year under the brand name Byooviz.
"In addition to various self-developed products, Samil Pharmaceutical is pursuing the realization of total care in the field of ophthalmic diseases by introducing products from global partners," said Samil Pharmaceutical CEO Huh Seung-beom. “We will continue to make efforts to provide more options to patients through our products."
Samsung Bioepis’ Executive Vice President and Commercial Division Leader Park Sang-jin said, "By launching Amelivu, we have been able to provide more treatment opportunities using high-quality drugs to patients with ophthalmic diseases in Korea, and will continue to improve patient benefits by expanding biosimilar prescriptions."
An official from Samil Pharmaceutical also added that Amelivu’s insured drug price of 463,773 won ($375.73) is expected to reduce the economic burden on patients by 43 percent of the original drug, Lucentis.