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 & Dr. Reddy | Image: Alvotech & Dr. Reddy
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
