Amneal, mAbxience Get FDA Nod for Two Denosumab Biosimilars

Amneal, mAbxience Get FDA Nod for Two Denosumab Biosimilars
Amneal, mAbxience Get FDA Nod for Two Denosumab Biosimilars
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Amneal Pharmaceuticals and mAbxience have received US FDA approval for two denosumab biosimilars—Boncresa and Oziltus. Boncresa is a biosimilar to Prolia, while Oziltus is a biosimilar to XGEVA.

Denosumab is used to treat bone-related conditions such as osteoporosis and certain cancers. Under their agreement, mAbxience will develop and manufacture the drugs, and Amneal will market them in the US.

Both medicines are given by healthcare professionals. Patients need to monitor calcium levels and seek medical help if they have allergic reactions.

Prolia is known to cause severe low calcium levels in some patients and should not be used during pregnancy. Common side effects include back pain, joint pain, and muscle problems. XGEVA can cause breathing issues, fatigue, nausea, and low phosphate levels. Both drugs may harm an unborn baby.

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