Otulfi®*, Fresenius Kabi’s Ustekinumab Biosimilar Developed by Formycon, Receives European Commission Approval

Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and Formycon AG, a leading, independent developer of high-quality biosimilars, announced today that the European Commission (EC) granted marketing authorization for its ustekinumab biosimilar candidate, indicated for the treatment of several serious inflammatory diseases. Fresenius Kabi is further continuing its momentum, striving at expanding its strong Biopharma business, which is a substantial cornerstone of #FutureFresenius.

“With the approval of Otulfi® in Europe, we expand our biosimilar portfolio with the fourth biosimilar. Our ustekinumab biosimilar is a testament to our dedication and commitment to better support patients’ treatment experience and clinical outcomes for patients across Europe. We are proud to continue delivering high-quality and affordable therapies for autoimmune diseases, while striving to ease the burden on local healthcare systems,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board.

In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. In March 2024, Formycon and Fresenius Kabi reached a settlement agreement with Johnson & Johnson concerning the commercialization of their ustekinumab biosimilar in Europe and Canada. The terms of the agreement are confidential.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The European Commission’s decision to issue a marketing authorization came after the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency’s (EMA) adopted a positive opinion in July 2024 to approve FYB202/Otulfi®. The EC decision is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference product Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). Fresenius Kabi received EC approval for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in Europe.

Otulfi® is Fresenius Kabi’s fourth biosimilar granted marketing authorization by the EC, following previous approvals of its commercially available biosimilars Idacio®*** (adalimumab), Tyenne®**** (tocilizumab) and Stimufend®***** (pegfilgrastim). Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development.