The Korea Times
Samsung Bioepis has announced a follow-up data of the phase 3 clinical trial of its osteoporosis biosimilar Obodence, demonstrating biological similarity between Obodence and its reference product, Prolia, the company said Sunday. The drug developer said it announced a subgroup analysis from its global phase 3 trial of Obodence at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases held in Prague from Thursday to Sunday. The analysis was conducted to assess how demographic characteristics, including age and body mass index, as well as disease-related factors such as fractures, affect treatment efficacy in 456 postmenopausal women with osteoporosis. Samsung Bioepis analyzed percentage changes from baseline in bone mineral density at the lumbar spine, total hip and femoral neck, 12 months after treatment with Obodence and Prolia, evaluating treatment effects before and after administration. Even after accounting for demographic and disease-related variables, the two drugs showed consistent efficacy across the subgroups, reaffirming their biological similarity se
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