- The FDA has approved two denosumab biosimilars, Boncresa™ and Oziltus™, developed and manufactured by mAbxience under a partnership with Amneal Pharmaceuticals.
- mAbxience will handle development and manufacturing, while Amneal holds exclusive U.S. marketing rights for the biosimilars.
mAbxience has announced that the U.S. Food and Drug Administration has approved the Biologics License Application for two denosumab biosimilars developed in partnership with Amneal Pharmaceuticals. The approvals cover Boncresa™ (denosumab-mobz), a Prolia®-referenced biosimilar, and Oziltus™ (denosumab-mobz), an XGEVA®-referenced biosimilar.
Under the collaboration, mAbxience is responsible for the development and manufacturing of the biosimilars, while Amneal holds exclusive marketing rights in the United States. Denosumab is a monoclonal antibody used to inhibit bone resorption and is prescribed for cancer- and osteoporosis-related conditions.
Amneal said the approvals expand its U.S. biosimilars portfolio to five marketed products, reinforcing biosimilars as a key part of its affordable medicines strategy. mAbxience said the decision reflects its scientific capabilities, manufacturing quality standards, and globalisation strategy in biologics.
“The FDA approval of our denosumab biosimilars marks a significant milestone for mAbxience and our collaboration with Amneal.”
Jurgen Van Broeck, Chief Executive Officer of mAbxience
