Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. Food and Drug Administration, FDA, has accepted a 351(k) Biologic License Application, BLA, submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia and Xgeva. “This milestone marks an important step in our mission to improve patient lives by expanding access to affordable and quality biologic medicines. We look forward to being able to serve the large population of patients requiring treatment for osteoporosis and other diseases of the bone,” said Joseph McClellan, Chief Scientific Officer for Alvotech.
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