Otulfi^*, Fresenius Kabi's Ustekinumab Biosimilar Developed By Formycon, Receives European Commission Approval

• Otulfi received European Commission (EC) approval for both subcutaneous and intravenous formulations, providing a high-quality treatment option for European patients treated with ustekinumab
• Otulfi is approved in the indications of moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis
• Otulfi is Fresenius Kabi’s fourth approved biosimilar in Europe, expanding its biosimilars portfolio focused on autoimmune diseases and oncology

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.

About Fresenius Kabi:
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.

Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.

Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.

About Formycon:
Formycon AG is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. FYB203/aflibercept-mrbb, received FDA approval, and FYB202/ustekinumab was approved in Europe. Another fthree biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.