Sandoz Faces US Denosumab Lawsuit Ahead Of Key 2025 Patent Expiry

Sandoz’s BLA Accepted For FDA Review In February; Denosumab Sales In Billions

 
• By Dean Rudge

Months after announcing that its GP2411 biosimilar denosumab candidate was accepted for filing by the FDA, Sandoz has been sued for alleged patent infringement by originator Amgen.

Grechanyuk Aleksandr/Alamy Stock Photo
• Source: Shutterstock (Grechanyuk Aleksandr / Alamy Sto/Alamy Stock Photo)

Sandoz may have to defend itself from patent infringement claims in a US district court after being sued by Amgen in response to Sandoz filing for a biosimilar to the originator’s Prolia/Xgeva (denosumab).

Amgen names 21 patents in the suit, filed in a federal district court in New Jersey

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