Formycon AG announced the successful conclusion of the extended Phase I clinical study comparing the pharmacokinetics of FYB202 and the reference drug Stelara. As early as August 2022, the primary endpoint was achieved in the randomized, double-blind, multicenter Phase III study (VESPUCCI), demonstrating the comparable efficacy of FYB 202 and the reference drug in patients with moderate-to- severe psoriasis vulgaris (plaque psoriasis). The positive results of the Phase I pharmacokinetics study successfully conclude the clinical development program.

FYB202 was bioequivalent to the reference drug Stelara sourced in the EU as well as in the U.S. for all primary endpoint parameters. European and U.S. regulatory submissions are still planned for the third quarter of 2023. provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.

The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, the originator medicine has been used to treat various severe inflammatory conditions such as moderate-to-severe psoriasis as well as psoriatic arthritis. Its approved indications were expanded to chronic inflammatory bowel diseases like treatment of Crohn's disease (2016) and ulcerative colitis (2019).