Ustekinumab biosimilar candidate

Our candidate biosimilar to Stelara®* (active ingredient: ustekinumab) is targeted at several different therapeutic indications involving serious inflammatory diseases.





Current development status

Preclinical phase
Clinical phase I
Clinical phase III

Scope of therapeutic indication

Ustekinumab, a human monoclonal antibody which targets the cytokines interleukin-12 and interleukin-23, is used for the treatment of several different serious inflammatory diseases, such as moderate to severe psoriasis. Its therapeutic indications were extended to also include the treatment of Crohn’s disease and ulcerative colitis, both chronic inflammatory bowel diseases. In addition, the drug is also indicated for the treatment of psoriatic arthritis.

Our development work

By applying dozens of analytical methodologies, we have been able to demonstrate its analytical comparability to the reference product. An efficient manufacturing process for our biosimilar candidate has been developed and is now in place.

The treatment of the last patient in the phase III clinical trial (VESPUCCI study) was successfully completed (last-patient-out) despite the current challenging environment for conducting clinical trials. Bioeq GmbH is the sponsor of the clinical study and responsible for the design and operative execution. We have, in addition, filed our own patent applications, such as in the area of drug formulation.

In early February 2023, Formycon, as the exclusive owner of the global commercialization rights, concluded a license agreement with Fresenius Kabi AG for the global commercialization of FYB202. Semi-exclusive commercialization rights for Germany as well as rights for parts of the MENA region (Middle East and North Africa) and Latin America remain with Formycon.

The market

Stelara® is an expensive medication, with its price ranging from roughly EUR 4,500 for one low-dose application in the European Union to roughly USD 19,000 for a higher-dosed application in the United States.

Global sales of this relatively new drug were around USD 10.9 billion in 2023, with growth continuing at a rapid rate. The potential use of ustekinumab for additional therapeutic indications offers additional revenue potential.

Next milestones

The clinical phase III study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB202 and the reference medicine Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). The primary endpoint measures the percent improvement of the Psoriasis Area and Severity Index (PASI) at 12 weeks from baseline. In addition, to date, no clinically meaningful differences in safety and immunogenicity have been observed.

The extended Phase I clinical study comparing the pharmacokinetics of FYB202 and the reference drug has been successfully concluded. In a next step European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023.

On September 29, 2023, Formycon announced the acceptance of the marketing authorization application for FYB202 by the European Medicines Agency (EMA). The biologics license application was accepted by the US Food and Drug Administration (FDA) on November 28, 2023. The FDA set a target action date of September 2024.

In August 2023, Formycon and its commercialization partner Fresenius Kabi announced the conclusion of a settlement agreement with Johnson & Johnson for the U.S. The settlement allows Fresenius Kabi and Formycon to launch their product FYB202, once approved by the FDA, in the US no later than April 15, 2025.

* Stelara® is a registered trademark of Johnson & Johnson