Formycon and Fresenius Kabi secure U.S. License Date for proposed Ustekinumab Biosimilar

Formycon and Fresenius Kabi entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed ustekinumab biosimilar in the U.S.
As per the settlement, FYB202 can be marketed in the U.S., subject to regulatory approval, no later than April 15, 2025
FYB202 is a human monoclonal antibody for treatment of immune-mediated disorders

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Fresenius Kabi today announced that they have reached a settlement with Johnson & Johnson for the U.S., concerning FYB202, a proposed ustekinumab biosimilar to Stelara®¹. 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.

“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.

“We are pleased to have reached a settlement and secured the U.S. license date to provide an alternative treatment option to health 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.”

In February 2023, Formycon announced a global license agreement with Fresenius Kabi 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.

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: www.formycon.com/

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 www.fresenius-kabi.com
For more information about the company’s work in biosimilars, please visit https://biosimilars.fresenius-kabi.com

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.

Disclaimer:
This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

Press & IR Contact
Sabrina Müller
Director Investor Relations and
Corporate Communications
T + 49 89 86 46 67 149
F + 49 89 86 46 67 110
sabrina.mueller@formycon.com

Formycon AG
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82152 Planegg/Martinsried
Germany
www.formycon.com