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Venable LLP

Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation...

Venable LLP on

On February 28, 2025, the FDA approved Celltrion’s Stoboclo® / Osenvelt® (denosumab-bmwo) as the third company to receive FDA approval of biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more

Goodwin

Year in Review: Top Legal Developments of 2024

Goodwin on

​​​​​​​As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big...more

Goodwin

Recent IPR Updates

Goodwin on

The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more

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