Blog Big Molecule Watch August 18, 2022

Formycon Announces Comparable Efficacy of Ustekinumab Biosimilar to Reference Product STELARA in Phase III Study

This week Formycon AG (“Formycon”) announced positive preliminary efficacy and safety data from the VESPUCCI Phase III clinical trial for FYB202, Formycon’s biosimilar version of STELARA (ustekinumab). The Phase III study was a multi-center, randomized, double-blinded, comparative study of patients with moderate to severe psoriasis vulgaris (plaque psoriasis). The clinical trial demonstrated comparable efficacy between FYB202 and STELARA. Further, no clinically meaningful differences in safety and immunogenicity were observed.

Formycon’s CEO Dr. Stefan Glombitza stated that, “[w]ith FYB202 we have a promising biosimilar candidate and are addressing an important and growing market in the inflammatory diseases segment,” and the “positive interim phase III study results mark an important milestone and underline our expertise in the development of high-quality biosimilars.” As we previously reported, Formycon had acquired 100% of the rights to FYB202 from ATHOS KG. According to the press release, Formycon has six biosimilars in development.

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