EMA Accepts Alvotech's Biosimilar Application for Stelara
The European Medicines Agency (EMA) has accepted a marketing authorization application for AVT04, Alvotech's proposed biosimilar to Stelara (ustekinumab), submitted with partner STADA. An opinion from the EMA could come as early as the second half of 2023.
Alvotech and its partner STADA have had their marketing authorization application for AVT04, a proposed biosimilar to Stelara® (ustekinumab), accepted for filing by the European Medicines Agency (EMA). The companies anticipate a potential recommendation for marketing authorization from the EMA as early as the second half of 2023.
The reference product, Stelara®, is used to treat various inflammatory conditions. If approved, AVT04 could expand patient access to more affordable biologic medicines in Europe, aligning with Alvotech's goal of developing and manufacturing multiple biosimilars simultaneously.
This acceptance marks a significant step towards potentially making a new treatment option available for inflammatory conditions to patients and physicians in Europe. For STADA, it would add to their existing portfolio of six approved biosimilars in Europe.
The partnership between Alvotech and STADA, formed in 2019, has already led to the launch of several biosimilars in European markets. Alvotech previously announced that confirmatory clinical studies for AVT04 met their primary endpoint, demonstrating therapeutic equivalence to the reference product.