Planegg-Martinsried – Formycon AG (FWB: FYB) will present clinical study data of its ustekinumab biosimilar candidate FYB202 at this year’s European Academy of Dermatology & Venerology (EADV) congress, taking place in Amsterdam from September 25 to 28, 2024. The randomized, double-blind, multicenter VESPUCCI Phase III study met the primary endpoint, demonstrating similar efficacy of FYB202 and the reference drug Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). The ePoster presentation shows details of the study design as well as the primary and secondary endpoints.

In addition, Formycon will present study data focusing on the pharmacokinetics of the ustekinumab biosimilar candidate FYB202 at the United European Gastroenterology (UEG) Week from October 12 to 15, 2024 in Vienna. In the Phase I pharmacokinetics study FYB202 showed bioequivalence to the reference drug for all primary endpoints.

Both posters were designed in cooperation with Fresenius Kabi, Formycon’s commercialization partner for FYB202.

Presentation details:

EADV Congress

  • Session: ePoster
  • Poster-ID: P0984
  • Title: A randomised, double-blind trial to compare the efficacy, safety, and immunogenicity of the proposed biosimilar ustekinumab (FYB202) with reference ustekinumab in patients with moderate-to-severe plaque psoriasis
  • Room: Poster Area
  • Date: September 25 – 28, 2024

UEG Week

  • Session: ePoster incl. audio/video presentation on demand
  • Poster-ID: PP0593
  • Title: Proposed ustekinumab Biosimilar FYB202: Pharmacokinetic equivalence demonstrated in a randomised, double-blind, parallel-group, single-dose trial in healthy subjects (RUSTIC)
  • Speaker: Sigrid Balser, Vice President Clinical Development & Operations, Formycon AG
  • Room: Poster Area
  • Date: October 13 – 15, 2024

FYB202 is an interleukin inhibitor that can be used both in dermatology for the treatment of psoriasis and in gastroenterology for the treatment of chronic inflammatory bowel disease. The biosimilar candidate is currently in the final phase of the approval process for the US and the European Union. The decision of the European Commission on the approval is expected in early Q4, while the decision of the FDA is anticipated by the end of September 2024.


1 Stelara® is a registered trademark of Johnson & Johnson