Shots:
- The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference products
- Approval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety, plus immunogenicity in postmenopausal osteoporosis
- Additionally, Fresenius & Amgen have reached a global settlement, allowing the US launch of these biosimilars from mid-2025 & their European launch in late H2’25, pending regulatory approval
Ref: Fresenius | Image: Fresenius
Related News:- Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency
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