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Prolia

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Mabwell’s 9MW0311 and 9MW0321 denosumab biosimilars have passed an ANVISA GMP inspection in Brazil, advancing manufacturing readiness as the company pursues Brazilian marketing authorisation. Representative image.
Pharma & Biotech

Could Brazil become Mabwell’s next denosumab biosimilar market after ANVISA GMP inspection?

Mabwell clears ANVISA GMP inspection for 9MW0311 and 9MW0321, advancing its denosumab biosimilar registration strategy in Brazil.

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Accord BioPharma’s U.S. launch of Osvyrti and Jubereq brings two interchangeable denosumab biosimilars into the increasingly competitive osteoporosis and oncology-support market. Representative image.
Pharma & Biotech

Jubereq launch: Accord BioPharma challenges Xgeva in cancer-related bone complications

Accord BioPharma launches Osvyrti and Jubereq as interchangeable denosumab biosimilars, testing price, payer access and provider adoption.

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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.
Pharma & Biotech

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

Find out how GlycoNex’s SPD8 Phase III data could intensify denosumab biosimilar competition in osteoporosis and oncology care.

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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

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

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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

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

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