• 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, Germany I August 07, 2023 I 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 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 four 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.

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, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.

SOURCE: Formycon