Formycon has concluded the development of its Stelara (ustekinumab) biosimilar FYB202, following an extended Phase I study on the pharmacokinetics of the drug. FYB202 was found to be bioequivalent to Stelara sourced in both the EU and US for all primary endpoint parameters.
A Phase III study demonstrating the comparable efficacy of Formycon’s biosimilar and its reference drug in patients with moderate-to-severe plaque psoriasis was completed in August 2022
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