Shots:
- The EMA has accepted the marketing authorization application of AVT03, a biosimilar version of Prolia & Xgeva (denosumab)
- Submission was based on the AVT03-GL-C01 trial among postmenopausal women (n=532) with osteoporosis as well as AVT03-GL-P01 (n=209) & AVT03-GL-P03 (n=208) studies among healthy adults, depicting similarity in efficacy, safety, immunogenicity & PK b/w the drugs
- Additionally, Alvotech will develop & manufacture AVT03, while STADA & Dr. Reddy’s hold semi-exclusive rights to commercialize it in the EU, incl. Switzerland & UK
Ref: Alvotech | Image: Alvotech | Press Release
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