FDA Approves Amneal and mAbxience Denosumab Biosimilars
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Amneal Pharmaceuticals Inc. and mAbxience have received FDA approval for their denosumab biosimilars, Boncresa™ and Oziltus™, referencing Prolia® and XGEVA® respectively. mAbxience developed and manufactured these biosimilars, while Amneal holds exclusive U.S. commercialization rights. This approval is a significant milestone, enhancing access to affordable biologic medicines in the U.S.
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