• Otulfi® received MHRA approval for both subcutaneous and intravenous formulations, to treat serious inflammatory diseases
  • UK approval follows the series of successful approvals by the FDA, the European Commission and Health Canada for FYB202/Otulfi® submissions
  • The earliest date for commercialization of Otulfi® in the UK is defined in a confidential settlement agreement between Formycon, Fresenius Kabi and Johnson & Johnson signed in March 2024

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its commercialization partner Fresenius Kabi announce that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®1 (ustekinumab), a biosimilar to Stelara®2, for the treatment of moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The U.S. Food and Drug Administration (FDA) as well as the European Commission had already granted marketing authorization for FYB202 in September 2024, followed by Health Canada’s approval end of December 2024.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “For millions of people around the world, chronic inflammatory diseases have a massive impact on the quality of life. There is a clear demand to help those patients, who are suffering severely from the symptoms of their disease. Each approval is important and brings us a step ahead in our mission to offer a highly effective and cost-efficient treatment option to as many patients as possible across multiple geographies.”

In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202 in key global markets, including the UK.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

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1) Otulfi® is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
2) Stelara® is a registered trademark of Johnson & Johnson