Fresenius Kabi, Formycon receive FDA nod for Stelara biosimilar

Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and Formycon AG, an independent developer of biosimilars, have received permission from the Food and Drug Administration for Otulfi (ustekinumab-aauz), a biosimilar of Johnson & Johnson’s Stelara (ustekinumab).

Otulfi is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. 

“The FDA approval of Otulfi, Fresenius Kabi’s fourth biosimilar product in the U.S. market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the United States and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally,” said Sang-Jin Pak, president biopharma and member of the Fresenius Kabi management board.

[Read more: Fresenius Kabi intros generic Tepadina]

In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and

Otulfi was approved for both subcutaneous and intravenous formulations, which will offer a comprehensive, alternative treatment solution for healthcare professionals and patients treated with ustekinumab in the United States, the company said.

[Read more: Fresenius Kabi intros generic Tepadina]