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Sandoz Gets US Denosumab Approvals – But When Will They Launch?

FDA Also Grants Interchangeability Designation For First Biosimilars To Prolia And Xgeva

 
• By Dave Wallace

Sandoz has received the first FDA approvals for denosumab biosimilar rivals to Prolia and Xgeva under the names Wyost and Jubbonti. However, the firm has declined to comment on launch details while it remains locked in litigation with originator Amgen.

Two Blue And Black Badges Representing FDA Approvals
Sandoz has received two denosumab biosimilar approvals • Source: Shutterstock

Sandoz has achieved a milestone in the US after receiving the first US Food and Drug Administration approvals for biosimilar rivals to Amgen’s denosumab-based Prolia and Xgeva brands – accompanied by the FDA granting interchangeability designations and approving indications that match all those of the reference brands.

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