bioeq’s third development product FYB202 is a biosimilar of Ustekinumab (Stelara®)1, owned by the FYB202 Project GmbH, a joint venture between Aristo Pharma GmbH and Formycon AG.
Stelara® is prescribed for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, moderate to severe active Crohn's disease as well as moderate to severe active ulcerative colitis. The development program is backed up by continuous and close alignment via scientific advice meetings with both, the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA).
bioeq started a global pivotal Phase III clinical trial in Sep 2020. The objective of this study is to demonstrate comparable safety, efficacy and immunogenicity of FYB202 to Stelara® in patients with moderate to severe plaque psoriasis. The introduction of FYB202 biosimilar to the market is anticipated in the US in 2023 and in Europe in 2024.
1 Stelara® is a registered trademark of Janssen