Sandoz Settlement Sets Date For US Denosumab Entry

Deal With Amgen Ends Litigation, Allowing Prolia/Xgeva Biosimilars To Launch Next Year

Sandoz has secured a launch date for its newly-approved US denosumab biosimilars, settling patent litigation with Prolia/Xgeva originator Amgen.

May 2025 calendar
Sandoz will be able to launch in May 2025 • Source: Shutterstock

After kicking off March with the announcement of US Food and Drug Administration approval for two denosumab biosimilars, Sandoz has closed out April by revealing that it has secured a launch date of 31 May 2025 for the products through a litigation settlement with originator Amgen.

Sandoz early last month received an FDA nod for its Wyost (denosumab-bddz) and Jubbonti (denosumab-bddz) rivals to Amgen’s Xgeva and Prolia brands, representing the first denosumab biosimilars approved by the

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