Tagged as: XGEVA

Amneal Expands Oncology Offering with Two Denosumab Biosimilars

On October 12, Amneal announced that it will be adding two denosumab biosimilars to its oncology pipeline, referencing PROLIA and XGEVA. Denosumab is indicated for bone metastasis from various forms of cancer and for the prevention of bone pain and fractures, including osteoporosis-related injuries. Amneal announced that mAbxience will develop…

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Purple Book Updates

FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance.  Pursuant to a law enacted in late 2020, a reference product sponsor must provide patent information to FDA for listing in the Purple Book once…

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Sandoz Denosumab BLA Accepted by FDA

The US FDA has accepted a Biologics License Application (BLA) from Sandoz for a proposed denosumab biosimilar. In its press-release, Sandoz stated that the “application includes all indications covered by the reference medicines Prolia® (denosumab)* and Xgeva® (denosumab)* for treating a variety of conditions, including osteoporosis in postmenopausal women and…

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China Approves World’s First Denosumab Biosimilar

Luye Pharma Group announced last week that China’s National Medical Products Administration has approved a marketing launch of BOYOBEI® for treatment of postmenopausal women with osteoporosis at high risk of fractures.  Luye Pharma Group, in conjunction with its subsidiary Boan Biotech, is now the first company in the world to receive…

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