Sandoz Faces US Denosumab Lawsuit Ahead Of Key 2025 Patent Expiry
Sandoz’s BLA Accepted For FDA Review In February; Denosumab Sales In Billions
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.
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CEO of Enzene Biosciences weighs in on the impact of Medicare negotiations in the US on the biosimilars market even as a US filing is planned for a Prolia biosimilar. In the interview, he says Enzene “is not afraid or concerned” over ongoing litigation with Merck KGaA over an Erbitux biosimilar in India, adding that new modalities like ADCs are being “seriously” considered.
Fresenius Kabi has welcomed “another testimonial of our efforts to expand our biosimilar portfolio,” with an update for its FKS518 biosimilar denosumab candidate.
Sandoz has confirmed dual European filings for its denosumab biosimilar rival to Prolia and Xgeva, a few months after it submitted its candidate in the US.