Alvotech Reports the EMA’s Acceptance of MAA for AVT03 (Biosimilar, Prolia and Xgeva)
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
Related News:- Alvotech Reports the Initiation of Confirmatory Trial of AVT16 (Biosimilar, Entyvio)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
