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The U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Samsung Bioepis’ PYZCHIVA (ustekinumab-ttwe) subcutaneous injection and intravenous infusion as a biosimilar to Johnson & Johnson’s immunotherapy Stelara (ustekinumab).
INCHEON, South Korea, July 01, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for PYZCHIVA® (ustekinumab-ttwe) subcutaneous injection and intravenous infusion as a biosimilar to Stelara1 (ustekinumab). PYZCHIVA has been approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. Additionally, a provisional determination was granted for PYZCHIVA’s interchangeability.
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Post-hoc analysis of Phase 3 study to highlight transfusion avoidance results of SB12 compared to reference eculizumab-treated groups INCHEON, Korea, May 30, 2024 (GLOBE NEWSWIRE) -- Samsung...
INCHEON, Korea, May 27, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today presented follow-up results from Phase 3 study on SB16, a proposed biosimilar to Prolia1 (denosumab) as oral presentation at the 2024 European Calcified Tissue Society (ECTS) Congress being held from May 25th to 28th in Marseille, France. The results up to Month 12 from Phase 3 study were previously presented at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting, and the new data presented today are the results of the switching period, showing SB16 and reference denosumab were comparable up to Month 18.