Samsung Bioepis Initiates Phase 1 Clinical Trial for Ninth Biosimilar
[Asia Economy Reporter Cho Hyun-ui] Samsung Bioepis has selected the skeletal disease treatment 'SB16' (generic name denosumab) as a new biosimilar (biopharmaceutical generic) pipeline and has started Phase 1 clinical trials. SB16 is the ninth biosimilar.
Samsung Bioepis announced on the 10th that since last month, it has begun a Phase 1 clinical trial in France involving 168 healthy adult males to verify the safety and immunogenicity of SB16.
SB16 is a biosimilar of 'Prolia,' a skeletal disease treatment developed by Amgen in the United States. Prolia, used for treating osteoporosis or bone loss in cancer patients, had global sales of approximately KRW 3.1 trillion (USD 2.672 billion) last year.
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Samsung Bioepis stated, "With the Phase 1 clinical trial of the ninth biosimilar pipeline 'SB16,' we have embarked on the development of a new antibody therapy," adding, "We will continue to expand our diverse product portfolio going forward."
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