Shots:
- The US FDA has approved Ponlimsi, a biosimilar version of Prolia (denosumab), for all indications of the reference product
- Approval was based on extensive clinical data, incl. analytical & clinical studies, which showed comparable efficacy, safety, & immunogenicity of Ponlimsi to the reference product
- Additionally, Teva’s biosimilar of Xolair (omalizumab) was accepted for review by the US FDA & EMA across all approved indications, backed by a comprehensive package of analytical & clinical data showing similar efficacy, safety, & immunogenicity to the reference product
Ref: Teva | Image: Teva | Press Release
Related News: Alvotech and Teva Enter into an Agreement with Regeneron to Launch AVT06 (Biosimilar, Eylea) Across US
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