Prolia® / Xgeva® Biosimilar Updates: Alvotech / Dr. Reddy’s AVT03 aBLA Acceptance, Fresenius Kabi’s Conexxence™ / Bomyntra™ FDA-Approval
By EsqSocial Corporation 03/04/25
On March 18, 2025, Alvotech and Dr. Reddy’s announced the FDA acceptance of an aBLA for AVT03 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab). Under their agreement, Alvotech is responsible for the development and manufacture of AVT03, and Dr. Reddy’s is responsible for its registration and commercialization....
By: Venable LLP