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Samsung Bioepis Snags Second EU Denosumab Biosimilar – But More Are On The Way

Rivals To Prolia And Xgeva Receive Endorsement From EMA’s CHMP

 
• By Dave Wallace

Samsung Bioepis may be only the second company to obtain an EMA positive opinion for a denosumab biosimilar, but plenty more rivals are on the way with filings of their own.

More rivals are lining up behind Samsung Bioepis and Sandoz (Shutterstock)

Samsung Bioepis has become only the second firm to gain a European Medicines Agency endorsement for its denosumab biosimilars to Prolia and Xgeva, with the agency’s Committee for Medicinal Products for Human Use issuing positive opinions for the company’s rival versions under the names Obodence and Xbryk.

While CHMP positive opinions do not constitute formal approval, the European Commission typically acts to convert them into pan-European marketing...

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