Samsung Bioepis said Tuesday that it has received Ministry of Food and Drug Safety (MFDS) approval for phase 3 clinical trial for SB11 (Original: Lucentis), a macular degeneration treatment.
The domestic trial, which is a part of the global phase 3 clinical trials, will be participated by 140 patients with neovascular age-related macular degeneration (AMD) and conducted at local hospitals such as Seoul National University Hospital서울대병원, Samsung Medical Center삼성서울병원, Severance Hosptial세브란스병원, Seoul St. Mary’s Hospital서울성모병원 and Asan Medical Center서울아산병원.
The clinical trial will compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB11 and Lucentis.
Macular degeneration is known to cause blindness and has been increasing due to the population aging. The current products in the market are also expensive and inconvenient making a high demand in the market for a new therapeutic drug.
Companies such as Hanlim Pharmaceuticals한림제약, BIOCND and Cha Bundang Medical Hospitals분당차병원 are also known to be developing a new treatment for the disease.
The newly approved phase 3 clinical trial for SB11 has raised the company’s 삼성바이오에피스 biosimilar pipeline to a total of seven products.
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