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Sandoz Maintains Lead On Denosumab With First EU Recommendations

CHMP Positive Opinions Follow Soon After First USFDA Approvals

 
• By Dean Rudge

Sandoz has again demonstrated its clout in the biosimilars space, taking a major step towards obtaining pan-European marketing authorizations for its biosimilar Prolia/Xgeva products.

European flags (Markus Pfaff/Shutterstock.com)
• Source: Shutterstock

Weeks after obtaining the first US Food and Drug Administration approvals, Sandoz has become the first player to scoop positive opinions in the EU recommending the granting of pan-European marketing authorizations for its biosimilars to Amgen’s Prolia/Xgeva products, Jubbonti and Wyost respectively.

The recommendations came from European Medicines Agency’s Committee for Medicinal Products for Human Use, which will now forward its recommendations to the European

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