Formycon AG from Martinsried near Munich and its commercialization partner Fresenius Kabi have received approval from the European Commission for the biosimilar FYB202 (Otulfi®) for the treatment of severe inflammatory diseases. The biosimilar is based on the active ingredient ustekinumab, which is used to treat diseases such as psoriasis and Crohn's disease.
With the market approval of FYB202, a further treatment option is now available that can be used as an alternative to existing therapies. Ustekinumab is already an established active ingredient in the treatment of chronic inflammatory diseases. The approved biosimilar was tested for efficacy and safety in clinical trials and found to be comparable to the original product.
The approval of FYB202 expands the range of therapies available to patients in the European Union, particularly in terms of potentially wider availability. Formycon and Fresenius Kabi are collaborating on the development and commercialization of this biosimilar, which will be available throughout the EU following approval.
Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, which play a central role in inflammatory and immune responses. The European Commission granted marketing authorization for FYB202 (Otulfi®), a biosimilar to Stelara®, after the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation in July 2024. This recommendation relates to the indications moderate to severe Crohn's disease, plaque psoriasis and psoriatic arthritis.
In February 2023, Formycon and Fresenius Kabi entered into a global commercialization partnership for FYB202 in key global markets. The semi-exclusive commercialization rights for Germany, parts of the MENA region and Latin America remain with Formycon. In March 2024, Formycon and Fresenius Kabi entered into a settlement agreement with Johnson & Johnson for the commercialization of their ustekinumab biosimilar in Europe and Canada. The terms of the agreement are confidential. Stelara® is one of the ten top-selling pharmaceutical brands in Europe with annual sales of over EUR 2.5 billion.