Amgen sues Sandoz to block biosimilar of blockbuster bone drug
Amgen is suing Sandoz in federal court over the company’s plan to seek FDA approval of a biosimilar version of denosumab, alleging 42 instances of patent infringement for the blockbuster biologic.
The complaint, filed Monday in New Jersey, names Sandoz, its subsidiary Lek Pharmaceuticals, and its parent company Novartis. The lawsuit centers on Sandoz’s plan to bring to market a biosimilar version of denosumab — branded as Prolia and Xgeva. Sandoz’s BLA for a biosimilar version of the antibody was accepted by the FDA in February.
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