Formycon and Fresenius Kabi Receive FDA Approval for Biosimilar Otulfi

Formycon AG and Fresenius Kabi have announced the FDA approval of FYB202/Otulfi (ustekinumab-aauz), a biosimilar to Stelara, for subcutaneous and intravenous use. This marks Formycon's third FDA-approved biosimilar, with two approvals in 2024 alone. FYB202 is approved for treating Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

Under a patent settlement, Fresenius Kabi can market Otulfi in the US by February 22, 2025. The biosimilar has shown comparable efficacy and safety to Stelara, which earned over $10 billion in global sales in 2023.

Dr. Stefan Glombitza, CEO of Formycon, highlighted the approval as a significant milestone aligning with their goals to enhance accessibility to biologic therapies. CFO Enno Spillner emphasized the financial benefits, forecasting that FYB202 will bolster Formycon’s profitability.