Fresenius Kabi announces global license agreement with Formycon AG to commercialize proposed Ustekinumab biosimilar

February 2, 2023

Fresenius Kabi will commercialize Formycon’s Ustekinumab biosimilar candidate (FYB202) in key global markets after successful approval by respective health agencies

The biosimilar candidate further expands Fresenius Kabi’s autoimmune biosimilars portfolio

The proposed biosimilar is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 for treatment of immune-mediated disorders

Lab Switzerland Fresenius Kabi

Fresenius Kabi, a global health care company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions, announced today that it has entered into a global license agreement with Formycon AG, to commercialize a proposed Ustekinumab biosimilar candidate (FYB202) being developed by Formycon AG. The proposed biosimilar is currently in advanced clinical stage.

FYB202 is a proposed biosimilar referencing Johnson & Johnson’s Stelara®*, 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.

The global license agreement gives Fresenius Kabi exclusive rights to commercialize the proposed Ustekinumab biosimilar product in key global markets. Fresenius Kabi holds semi-exclusive commercialization rights for Germany as well as rights for parts of the MENA** region and Latin America. Under the agreement, Fresenius Kabi will be responsible for commercialization of the product, while Formycon AG will be responsible for development and registration with health authorities. Formycon AG is eligible to receive upfront and milestone payments contingent on the successful achievement of certain regulatory events, with post-commercialization value to be shared approximately equally by both companies.

“With the commercialization of the Ustekinumab biosimilar we are expanding our product portfolio with another autoimmune disease treatment option. In line with Vision 2026, this is yet another key milestone for Fresenius Kabi in delivering on our strategic priority of providing access to biosimilars for patients worldwide,” said Dr. Michael Schönhofen, Fresenius Kabi’s Chief Operating Officer and Member of the Fresenius Kabi Management Board. “We welcome the potential of this agreement to build on the strengths of our companies across the value chain from development to commercialization.”

"We are delighted about the conclusion of the agreement and are looking forward to a successful commercialization of our Ustekinumab biosimilar candidate after approval. The combination of Formycon’s development expertise and Fresenius Kabi’s global commercial competence offers an excellent basis for providing access to our highly efficacious product to many patients,” says Nicola Mikulcik, Chief Business Officer at Formycon AG.

* Stelara® is a registered trademark of Johnson & Johnson
** Middle East and Northern Africa

About Fresenius Kabi:

Fresenius Kabi is a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the devices for administering these products. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, the first biosimilar product by Fresenius Kabi was launched. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for collection of blood components and extracorporeal therapies.

With its corporate mission of "caring for life", the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face.

Fresenius Kabi employs more than 41,000 people worldwide. In 2021, the company reported sales of more than €7.2 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA healthcare group.

For more information visit the company’s website at

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. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207. 

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