Dr. Reddy's Laboratories (RDY) and Alvotech (ALVO) said Tuesday that the US Food and Drug Administration has accepted a biologic license application submission for AVT03, a proposed biosimilar of bone disease treatments Prolia and Xgeva.
Dr. Reddy's and Alvotech last year entered into a license and supply agreement for AVT03 under which Alvotech is responsible for the development and manufacturing of the drug, while Dr. Reddy's is responsible for registration and commercialization.
Alvotech shares were up more than 2% in premarket trading, while Dr. Reddy's was up 0.5%.
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