• 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