Shots:
- The EC has approved AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab), in 60mg/mL PFS (Prolia) & 70mg/mL single-use vial (Xgeva) presentation
- Approval was based on extensive clinical data, incl. analytical, PK & PD data, plus data from AVT03-GL-C01 trial (vs Prolia) among postmenopausal women with osteoporosis, as well as AVT03-GL-P01 trial (vs Prolia) in healthy adult males, depicting similarity in efficacy, safety, immunogenicity & PK b/w the drugs
- In EU, AVT03 will be commercialized by STADA & Dr. Reddy’s, each holding semi-exclusive rights across the EEA, Switzerland & the UK; STADA will market it as Kefdensis/Zvogra, & Dr. Reddy’s as Acvybra/Xbonzy
Ref: Alvotech | Image: Alvotech | Press Release
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