MUNICH, Germany I March 18, 2024 I Formycon AG (FSE: FYB) and its commercialization partner Fresenius Kabi today announced the signing of a settlement agreement with Johnson & Johnson concerning the commercialization of FYB202, a biosimilar to Stelara®1 (ustekinumab), in Europe and Canada. It was agreed to keep the terms of the agreement confidential.

Nicola Mikulcik, Chief Business Officer of Formycon AG, commented: “Achieving this settlement is testament to our strategic approach of ensuring we make early preparations to expand patient access to critical treatments. Our aim is to make a significant difference in patients’ lives by providing them with reliable, high-quality, and affordable treatment options. Following the settlement for the US, this is another important step that underlines the joint effort of Formycon and Fresenius Kabi, and it solidifies our position to make FYB202 accessible in key global markets.”

FYB202 is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 and is used for the treatment of various severe immune-mediated disorders. Stelara® is approved for the treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis. The marketing authorization application for FYB202 was accepted for review by the European Medicines Agency (EMA) in September 2023 and by the U.S. Food and Drug Administration (FDA) in November 2023. In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement for the ustekinumab biosimilar candidate FYB202, under which FYB202 will be marketed by Fresenius Kabi in key global markets following successful approval.

1)  Stelara® is a registered trademark of Johnson & Johnson.

About Formycon:
Formycon AG (FSE: FYB) 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. Another five 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. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at:

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.

For more information visit the Fresenius Kabi’s website at
For more information about the company’s work in biosimilars, please visit

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars.

Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures.

Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare providers. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

SOURCE: Formycon