Fresenius Kabi and Formycon Announce EMA Submission Acceptance of the Marketing Authorization Application for FYB202, an Ustekinumab Biosimilar Candidate

September 29, 2023

Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, and its license partner Formycon AG, a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars, announced today that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for FYB202, a proposed ustekinumab biosimilar candidate to Stelara®*.

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

Doctor with vial

“Today marks another milestone in our journey towards advancing healthcare accessibility and the provision of high-quality, affordable treatment options to patients across Europe. The MAA acceptance for review of biosimilar candidate FYB202 is a testament to the dedication and expertise of our teams and the company’s Vision 2026 growth strategy. At Fresenius Kabi, we believe in the power of biosimilars to transform patient care and contribute to the sustainability of healthcare systems,” said Dr. Michael Schönhofen, Fresenius Kabi President Biopharma. 

“With the current FYB202 submission, we are very proud of having brought our third biosimilar pipeline candidate onto the regulatory pathway. The EMA acceptance of the marketing authorization application brings us one step closer to offering broader access to another affordable and important high-quality biosimilar treatment option for patients with chronic immune-mediated inflammatory diseases in Europe,” commented Dr. Stefan Glombitza, CEO of Formycon AG.

In February 2023, Fresenius Kabi and Formycon AG entered into a global license agreement to commercialize the proposed ustekinumab biosimilar (FYB202) in key global markets after successful regulatory approvals. 

* Stelara® is a registered trademark of Johnson & Johnson

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.

With its corporate mission of "caring for life", 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 “Vision 2026”, 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.

For more information, please visit

About Formycon:

Formycon (ISIN: DE000A1EWVY8 / WKN: A1EWVY) is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has six biosimilars in development. 

For more information visit the company’s website at


This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.
Management Board: Pierluigi Antonelli (Chairman), Marc Crouton, John Ducker, Andreas Duenkel, Dr. Christian Hauer, Dr. Michael Schönhofen
Chairman of the Supervisory Board: Michael Sen
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg - HRB 11654