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NEWS

GlycoNex Doses Last Patient in P-III Trial of SPD8 (Biosimilar, Prolia/Xgeva) to Treat Osteoporosis

Shots:GlycoNex has dosed the last patient with SPD8, a biosimilar version of Prolia/Xgeva (denosumab), in its P-III trial for the treatment of primary osteoporosis from solid tumorsTrial will assess the PK, efficacy, & safety of SPD8 vs reference denosumab in postmenopausal women with osteoporosis; top-line results are expected in Q2’26 & data will support…
October 31, 2025

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Celltrion
NEWS

The FDA Grants Interchangeability Designation to Celltrion’s Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots:The US FDA has granted interchangeable designation to Stoboclo & Osenvelt, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for all approved indications of the reference productDesignation was based on extensive data, incl. analytical data demonstrating similarity of Stoboclo & Osenvelt with reference product & P-III trial results in postmenopausal women with osteoporosis, which showed comparable…
October 30, 2025

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Fresenius Kabi
NEWS

Fresenius Kabi’s Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) Receives FDA’s Interchangeable Designation

Shots:The US FDA has granted interchangeable designation to Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for the treatment of bone & skeletal disordersConexxence treats adults at high fracture risk, incl. pts with osteoporosis, pts on long-term glucocorticoid therapy or certain cancer treatments affecting bone densityBomyntra prevents SREs in adults with bone-involved malignancies…
October 30, 2025

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NEWS

Biocon Biologics Obtains the US Market Launch Date for Bosaya and Aukelso (Biosimilar, Prolia & Xgeva)

Shots:Biocon Biologics & Amgen have entered into a settlement & license agreement, allowing the US launch of Bosaya (60mg/mL, SC, PFS) & Aukelso (70mg/mL, SC, single-dose vial), provisional interchangeable biosimilars to Prolia & Xgeva (denosumab) by Oct 1, 2025Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya…
October 3, 2025

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Henlius & Organon
NEWS

Henlius and Organon Receive the EC’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots:The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference productApproval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumabIn 2022, Henlius…
September 22, 2025

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CuraTeQ
NEWS

CuraTeQ Biologics Reports Positive P-III study results for Denosumab biosimilar for postmenopausal osteoporosis 

Shots: CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported positive P-III results for its denosumab biosimilar targeting postmenopausal osteoporosis, as an alternative to Prolia The study involved 446 postmenopausal women across 40 sites in EU met all EPs, showing no significant differences between the biosimilar and Prolia The trial confirmed the biosimilar's efficacy in improving…
September 19, 2025

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NEWS

STADA Receives the CHMP’s Positive Opinion for Kefdensis and Zvogra (Biosimilar, Prolia & Xgeva)  

Shots: The CHMP has recommended Kefdensis and Zvogra, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders Kefdensis (biosimilar to Prolia) received CHMP approval for treating osteoporosis in high-risk postmenopausal women and men with an increased risk of fractures. Zvogra (biosimilar to Xgeva) received CHMP approval for preventing skeletal events…
September 19, 2025

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NEWS

Alvotech Reports Marketing Approval of Three New Biosimilars Across Japan 

Shots: Alvotech has reported that its partner Fuji Pharma has received Japanese approval for three biosimilars: AVT03 (Biosimilar, Ranmark), AVT05 (Biosimilar, Simponi), and AVT06 (Biosimilar, Eylea)  In Japan, AVT03 (denosumab-biosimilar to Ranmark/Xgeva) was approved for bone lesions from multiple myeloma or solid tumor metastases; AVT05 (golimumab biosimilar to Simponi) for rheumatoid arthritis Pts. who are…
September 19, 2025

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