Shots:
- The EC has approved Ponlimsi & Degevma, biosimilar versions of Prolia & Xgeva (denosumab), respectively, following the CHMP positive opinion for bone health treatments
- Approval was based on comprehensive analytical, preclinical, & clinical data, demonstrating comparable quality, safety, & efficacy of Ponlimsi & Degevma to the reference product
- Ponlimsi & Degevma are anti-RANKL monoclonal antibodies that will be available in 60mg/1mL PFS & 120mg/1.7mL vial presentation, respectively
Ref: Teva | Image: Teva | Press Release
Related News: Teva and Prestige Biopharma Sign a Licensing Agreement to Commercialize Tuznue (Biosimilar, Herceptin) Across EU
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