Fresenius Kabi, Formycon secure U.S. license date for proposed Stelara biosimilar

Fresenius Kabi and Formycon AG announced recently that they have reached a settlement with Johnson & Johnson for the United States, concerning FYB202, a proposed ustekinumab biosimilar to Stelara. The settlement allows Fresenius Kabi and Formycon to launch their product, once approved by the Food and Drug Administration, in the United States 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.

“We are pleased to have reached a settlement and secured the U.S. license date to provide an alternative treatment option to heathcare providers and patients living with immunology diseases in the United States,” said 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 United States while reducing the burden on the healthcare system.”

[Read more: 7 companies are rolling out Humira biosimilars]

“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 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,” said Nicola Mikulcik, chief business officer of Formycon AG.

In February 2023, Fresenius Kabi announced a global license agreement with Formycon AG to commercialize the proposed ustekinumab biosimilar (FYB202) in key global markets after successful approvals.

[Read more: Fresenius Kabi receives FDA approval for Humira biosimilar]