Formycon and Bioeq Report First Patients Dosing in P-III Study of FYB202 (biosimilar- ustekinumab)
Shots:
- The focus of the P-III study is to demonstrate the comparability of FYB202 & the reference product Stelara in terms of efficacy- safety & immunogenicity in patients with moderate to severe psoriasis vulgaris
- FYB202 is being developed as part of JV b/w Aristo Pharma & Formycon along with Bioeq. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US FDA & the EMA
- The ustekinumab is mAb targeting the cytokines IL-12 & IL-23. Stelara is used to treat various severe inflammatory conditions such as mod. to sev. psoriasis- CD & for UC
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