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Accord’s Denosumab Biosimilars Get Thumbs-Up From EMA

As Another Ustekinumab Rival Receives A Positive Opinion And An Insulin Filing Is Withdrawn

 
• By Dave Wallace

Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.

The CHMP endorsed more biosimilars in March (Shutterstock)

The latest meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use has seen Accord Healthcare win positive opinions for its two denosumab biosimilars, at the same time as Celltrion has gained an endorsement for a second ustekinumab biosimilar.

While CHMP positive opinions do not constitute formal approval, they are typically converted into pan-European marketing authorizations by the European...

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