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…And Amgen Makes Three: Another Ustekinumab Biosimilar Gets Go-Ahead In EU

Third Stelara Rival, Wezenla, Receives Positive Opinion From EMA’s CHMP In April Meeting

 
• By Dave Wallace

At the latest meeting of the EMA’s CHMP committee, the agency recommended that Amgen be granted a third European marketing authorization for a Stelara biosimilar.

Three Numbered Pool Balls With Cue And White Ball
Three Stelara biosimilars have now been cued up in Europe • Source: Shutterstock

Amgen has become the third firm to win a positive opinion from the European Medicines Agency for a Stelara (ustekinumab) biosimilar, after its Wezenla version was endorsed by the agency’s Committee for Medicinal Products for Human Use in its April meeting.

While CHMP positive opinions do not constitute formal approval, the European Commission typically acts within 67 days to convert

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