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News

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva) 

Shots: 

  • The US FDA has accepted 351(k) BLA of AVT03, a biosimilar version of Prolia & Xgeva (denosumab), for all indications of reference product 
  • As per the 2024 license & supply agreement, Alvotech is responsible for the development & manufacturing of AVT03, while Dr. Reddy’s handles registration & marketing in licensed regions, incl. the U.S. 
  • AVT03 is a fully human anti-RANKL mAb that will be available in single-dose pre-filled syringes (60mg/1mL) & single-dose vials (120mg/1.7mL or 70mg/mL) post approval    

Ref: Alvotech | Image: Alvotech and Dr. Reddy’s| Press Release

Related News:- Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US

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