Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara® (ustekinumab), today announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”). Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.

Upon conclusion of the agreement Formycon receives an upfront payment as well as milestone payments contingent on the successful achievement of certain regulatory events which are expected to total in the mid double digit million Euro range. Post-commercialization value will be shared approximately equally by both companies. Semi-exclusive commercialization rights for Germany as well as rights for parts of the MENA2 region and Latin America remain with Formycon.

In August 2022, Formycon published positive interim results for efficacy for FYB202 from the clinical phase III study VESPUCCI. In the extended phase I pharmacokinetics study, the recruitment of study subjects was successfully completed in October 2022. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023.

FYB202 is a proposed biosimilar referencing Johnson & Johnson’s Stelara®, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders. Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis.


1) Stelara® is a registered trademark of Johnson & Johnson
2) Middle East and North Africa