Amgen Files BPCIA Complaint Against Sandoz Over Denosumab Biosimilar

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Amgen Files BPCIA Complaint Against Sandoz Over Denosumab Biosimilar


  • Amgen filed a BPCIA complaint against Sandoz related to Sandoz’s denosumab biosimilar of Prolia and Xgeva in the District of New Jersey. Amgen also claims that the US FDA approval decision on the biosimilar candidate could come before its relevant patents expire.
  • Amgen is seeking a judgment of infringement and an injunction prohibiting the production and sale of the proposed biosimilar before the patent expiration dates
  • Prolia was the first biologic approved to treat osteoporosis while Xgeva was used to prevent skeletal-related events (e.g., fractures or spinal cord compression) in cancer patients. Both drugs contain denosumab as their active ingredient

Ref: Bigmoleculewatch | Image: Amgen

Related News:- Sandoz Reports the EMA Acceptance of MAA for Proposed Biosimilar Denosumab

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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