Fresenius Kabi and Formycon Secure U.S. License Date for Proposed Ustekinumab Biosimilar

August 7, 2023

Fresenius Kabi and Formycon AG entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed ustekinumab biosimilar in the U.S.

As per the settlement, FYB202 (ustekinumab biosimilar) can be marketed in the U.S., subject to regulatory approval, no later than April 15, 2025

The proposed biosimilar is a human monoclonal antibody for treatment of immune-mediated disorders

Fresenius Kabi Ustekinumab biosimilar

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 Formycon AG, a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars announced today that they have reached a settlement with Johnson & Johnson for the U.S., concerning FYB202, a proposed ustekinumab biosimilar to Stelara®. The settlement allows Fresenius Kabi and Formycon to launch their product, once approved by the FDA, in the US no later than April 15, 2025.

FYB202 is 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. 

“We are pleased to have reached a settlement and secured the U.S. license date to provide an alternative treatment option to heath care providers and patients living with immunology diseases in the U.S. ,” said Dr. Michael Schönhofen, Fresenius Kabi President Biopharma. “Bringing more biosimilars treatment solutions to the U.S. market is a core commitment of the company’s Vision 2026 growth strategy. With our continuously expanding pipeline we are becoming a significant player in the evolving field of biosimilars. This agreement takes us a step closer to providing patient access to reliable, high-quality, and safe biologic therapies across the U.S. while reducing the burden on the health care system.”

“While settlements are common practice to open the market for biosimilars, this agreement is a great achievement as it allows our partner Fresenius Kabi to launch FYB202 in the U.S. within the first launch-group of Ustekinumab biosimilars. We are on track to submit the Biologics License Application (BLA) later this year so that our partner can provide patients in the U.S. with a high-quality biosimilar by April 2025 at the latest.” commented Nicola Mikulcik, Chief Business Officer of Formycon AG.

In February 2023, Fresenius Kabi announced a global license agreement with Formycon AG to commercialize the proposed ustekinumab biosimilar (FYB202) in key global markets after successful approvals. Find further information about the former agreement in the Press Release.

* 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