FYB202
Ustekinumab biosimilar candidate
Our candidate biosimilar to Stelara®* (active ingredient: ustekinumab) is targeted at several different therapeutic indications involving serious inflammatory diseases.
Reference
Stelara®
Indication
Immunology
Current development status
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 then completed.
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 due to the corona pandemic.
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.
Formycon presented clinical study data of its ustekinumab biosimilar candidate FYB202 at the European Academy of Dermatology & Venerology (EADV) congress 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 2024. In the Phase I pharmacokinetics study FYB202 showed bioequivalence to the reference drug for all primary endpoints.
On June 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the approval of FYB202. The subsequent approval by the European Commission was granted end of September 2024.
The biologics license application was accepted by the US Food and Drug Administration (FDA) on November 28, 2023, and approved by September 27, 2024. In addition, FYB202 has received approval in Canada and the UK.
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
FYB202/Otulfi® was launched by Fresenius Kabi in the U.S. and Europe at the end of February / beginning of March 2025. Market launches in Canada and the UK are planned in the coming weeks and months.
* Stelara® is a registered trademark of Johnson & Johnson
