EC approval for FYB202/Otulfi, a Stelara biosimilar

27 September 2024

Germany-based Formycon (FSE: FYB) and it Fresenius Kabi jointly announce that the European Commission (EC) has issued a marketing authorization for FYB202/Otulfi, a biosimilar to Johnson & Johnson’s (NYSE: JNJ) Stelara.

The centralized marketing authorization is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses.

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