A Samsung Bioepis official introduces a follow-up data of the phase 3 clinical trial of the company's osteoporosis biosimilar Obodence during the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases held in Prague in this handout photo released Sunday. Courtesy of Samsung Bioepis

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 seen in the phase 3 trial results.

“Through the latest analysis, we were able to reaffirm Obodence’s consistent therapeutic efficacy across diverse patient populations,” said Shin Dong-hoon, executive vice president at Samsung Bioepis. “We will continue to strengthen our research and development capabilities to expand access to high-quality biologics based on scientific evidence.”

Prolia is an osteoporosis treatment developed by Amgen of the United States. Its 2025 global revenue stood at 6.4 trillion won ($4.41 billion), including 144.6 billion won in Korea.

Samsung Bioepis launched Obodence in Korea in July last year, and has been expanding its global market share by supplying the drug in the United States through private label arrangements with pharmacy benefit managers and by directly marketing it in Europe.

Source: Korea Times News