denosumab Archives - PharmaDeviceNews

Representative image of bone health biologics research as GlycoNex’s SPD8 Phase III result puts denosumab biosimilar competition, osteoporosis care, and oncology bone disease treatment under sharper focus.

GlycoNex targets Prolia and Xgeva space as SPD8 meets Phase III equivalence goal

by Pallavi Madhiraju
June 11, 2026
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Find out how GlycoNex’s SPD8 Phase III data could intensify denosumab biosimilar competition in osteoporosis and oncology care.

Representative image of osteoporosis research and denosumab biosimilar treatment, as Samsung Bioepis presents new SB16 subgroup efficacy data at WCO-IOF-ESCEO 2026.

Pharma & Biotech

Obodence at WCO 2026: Samsung Bioepis sharpens the clinical case for SB16 adoption

by Pallavi Madhiraju
April 20, 2026
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Samsung Bioepis presented new SB16 subgroup data at WCO 2026. Read what it means for Obodence adoption, biosimilar trust, and osteoporosis care.

Representative image illustrating biosimilar injectable medicines used in bone health and oncology care, reflecting the FDA approval of denosumab biosimilars by mAbxience and Amneal Pharmaceuticals and their potential impact on U.S. osteoporosis and cancer-related bone disease treatment markets.

Pharma & Biotech

FDA clears mAbxience–Amneal denosumab biosimilars, opening a new front in osteoporosis and oncology pricing

by Pallavi Madhiraju
January 4, 2026
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mAbxience and Amneal Pharmaceuticals have secured U.S. Food and Drug Administration (FDA) approval for two denosumab biosimilars, Boncresa and Oziltus, referencing Prolia and XGEVA respectively, clearing a long-anticipated regulatory hurdle in osteoporosis and oncology supportive care. The approvals position Amneal Pharmaceuticals as the exclusive U.S. commercial partner, with mAbxience responsible for development and manufacturing, marking