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STADA and Alvotech Launch First Approved Ustekinumab Biosimilar in Europe

Jul 22, 2024

On 22 July 2024, STADA and Alvotech announced the launch of biosimilar ustekinumab Uzpruvo® in Europe across the majority of European countries.  STADA and Alvotech plan to launch Uzpruvo® in additional European countries in the coming months, following national price approvals.  Uzpruvo® is the first biosimilar to Janssen’s Stelara® (ustekinumab) approved, and to be launched, in Europe.  The launch follows immediately on the expiry of the European molecule patent.

Uzpruvo® is the second immunology biosimilar brought to market through the strategic partnership between STADA and Alvotech, following the 2022 launch of Hukyndra® (high-concentration, citrate-free adalimumab).

Two other ustekinumab biosimilars are approved in Europe: Samsung Bioepis’  Pyzchiva® (April 2024) and Amgen’s WezenlaTM (June 2024).  On 1 July 2024, CHMP also recommended marketing authorisation for Celltrion’s Steqeyma (CT-P47, ustekinumab).