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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

Executive Summary

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.

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Stada and Alvotech’s Uzpruvo ustekinumab biosimilar is set to become the EU’s first approved rival to Stelara after the EMA’s CHMP issued a positive opinion for the product. Meanwhile, the committee also endorsed a Lucentis biosimilar from Qilu Pharma as well as azacitidine and paclitaxel generics from Fresenius Kabi and Accord.

Alvotech Receives CRL From FDA Over Ustekinumab Filing

Alvotech has announced that, “as expected”, its US filing for its AVT04 ustekinumab candidate has resulted in a complete response letter from the FDA over manufacturing facility deficiencies, following similar knockbacks for its adalimumab biosimilar. However, the firm anticipates an inspection and a new goal date for the proposed Stelara rival long before its planned February 2025 launch date.

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