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Stada And Alvotech Eye Potential EU Ustekinumab Nod This Year

A Frontrunner Filing For A Stelara Biosimilar Has Been Accepted For Review By The EMA

 
• By Dave Wallace

Alvotech and Stada have indicated that they could receive an EMA opinion on their AVT04 Stelara biosimilar as early as the second half of 2023, after the agency confirmed acceptance of their ustekinumab filing.

EMA
The EMA is examining Alvotech and Stada’s ustekinumab filing

Partners Stada and Alvotech have suggested that they could receive an opinion from the European Medicines Agency on their AVT04 proposed biosimilar to Stelara (ustekinumab) as early as the second half of 2023, after the EMA accepted the filing for review.

“The EMA has accepted a marketing authorization application for AVT04, Alvotech’s proposed biosimilar to Stelara,” the firms announced. “The companies...

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