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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

The EC Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots:The EC has approved Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab)Approval covers all indications of the reference products incl. osteoporosis in postmenopausal women & men at high risk of fracture, SRE prevention in adults with bone-involved malignancies, giant cell tumors of bone & treatment-related bone lossAdditionally, Fresenius & Amgen…
July 23, 2025

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Fresenius Kabi
NEWS

Fresenius Kabi Launches Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) in the US 

Shots: Fresenius Kabi launched Conexxence and Bomyntra, biosimilar of Prolia & Xgeva (denosumab) for all indications of the reference products across the US Conexxence (denosumab-bnht) 60 mg/mL, available in PFS, is approved for adults at high risk of fractures, including those with osteoporosis, pts. on cancer treatments affecting bone density, or long-term glucocorticoids  Bomyntra (denosumab-bnht)…
July 1, 2025

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Fresenius Kabi
NEWS

Fresenius kabi Secures the CHMP’s Positive Opinion for Bomyntra & Conexxence (Biosimilar, Prolia and Xgeva)

Shots: The CHMP has recommended a positive opinion for the marketing authorization of Bomyntra and Conexxence, biosimilars of Bayer’s Xgeva and Prolia (denosumab). EC approval is anticipated in Q3’25 The MAA submissions were based on comprehensive analytical similarity assessments and two comparative clinical studies: one on PK, PD, and immunogenicity in healthy volunteers, and another assessing efficacy, PD,…
May 27, 2025

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