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Alvotech and Dr. Reddy's
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. …
March 18, 2025

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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 …
October 10, 2024

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Alvotech and STADA Extend their Strategic Partnership Covering AVT03 (Biosimilar, Denosumab) 

Shots: Alvotech & STADA expand their strategic collaboration covering AVT03, biosimilar of Prolia/Xgeva (denosumab), to treat osteoporosis & cancer-related bone loss, respectively As per the agreement, AVT03 will be developed & manufactured by Alvotech at its state-of-the-art facility while STADA becomes marketing authorization holder with semi-exclusive commercial rights across the EU, incl. Switzerland & the…
June 11, 2024

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Alvotech Collaborates with Dr. Reddy’s to Commercialize AVT03 (Biosimilar, Prolia & Xgeva) 

  Shots: Alvotech & Dr. Reddy’s have signed a license & supply agreement to commercialize AVT03 under which Alvotech will handle the development & manufacturing activities. Dr. Reddy will get regulatory & commercial rights exclusively in US and semi-exclusively in the EU & UK  Alvotech will receive an upfront, regulatory & commercial milestones as well as…
May 21, 2024

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