Abbott Receives ANVISA’s Approval for Two Denosumab Biosimilars (Biosimilars, Prolia and Xgeva)
Shots:
- The ANVISA has approved two denosumab biosimilars (60 mg and 120 mg), a biosimilar version of Prolia and Xgeva in Brazil, expanding access to treatments for osteoporosis and cancer-related bone complications
- The P-III SIMBA study confirms that Abbott’s MB09 denosumab biosimilar demonstrates efficacy and safety comparable to the reference biologic, providing equivalent protection against bone loss in postmenopausal women
- In 2023, mAbxience and Abbott partnered to develop, manufacture, and supply denosumab biosimilars, with Abbott responsible for registration and commercialization across key emerging markets in LATAM, Southeast Asia, the Middle East, and Africa
Ref: Abbott | Image: Abbott | Press Release
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