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, safety, and immunogenicity in women with PMO
- The two applications cover all reference product indications, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of cancer-related bone complications, and giant cell tumors of the bone
Ref: Fresenius Kabi | Image: Fresenius Kabi | Press Release
Related News:- AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)
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