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SB44 is an investigational biosimilar candidate referencing Novartis's Ilaris (canakinumab). It is being developed by Samsung Bioepis in collaboration with Teva Pharmaceutical Industries for the treatment of various immunological and autoinflammatory diseases. SB44 is a human monoclonal antibody designed to target and neutralize interleukin-1 beta (IL-1β), a pro-inflammatory cytokine that plays a key role in the inflammatory cascade. By blocking IL-1β, SB44 aims to suppress systemic inflammation in conditions such as cryopyrin-associated periodic syndromes (CAPS), Still's disease (including systemic juvenile idiopathic arthritis and adult-onset Still's disease), and gout flares. Under their global partnership established in October 2026, Samsung Bioepis is responsible for the preclinical and clinical development, regulatory registration, and manufacturing of SB44, while Teva holds commercialization rights in major markets including the United States, Europe, and Canada.
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