Formycon AG and its commercialization partner Fresenius announce the commercial availability of Otulfi®1, a biosimilar to Stelara®2 in the United States (U.S.) and the European Union (EU). FYB202/Otulfi® is now commercially available in both subcutaneous and intravenous formulations in the United States and the European Union. Classification as an interchangeable biosimilar in the USA is expected in the near future.
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. Otulfi® was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in September 2024, having successfully met the agency’s standards for biosimilarity to the reference product, including equivalent efficacy, safety and pharmacokinetics.
In the U.S., Otulfi® is indicated for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The FDA has provisionally determined that Otulfi® will be interchangeable with the reference drug Stelara®, following the expiration of a competitor’s interchangeability exclusivity. In the EU, Otulfi® has been launched to treat moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis.
In February 2023, Formycon and Fresenius had entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202/Otulfi® in key global markets, including the U.S. and the EU.
Dr. Stefan Glombitza, CEO of Formycon AG, said: “With the launch of Otulfi® in these key global markets, patients, healthcare professionals and payors will have access to a biosimilar with the same efficacy and safety as Stelara® but at a lower cost. For many patients worldwide suffering from chronic inflammatory diseases, biologic therapies are inaccessible, and many patients experience significant delays before they can benefit from this highly effective treatment. The launch of Otulfi® will provide enhanced treatment access and choice.”
Otulfi® will be available in the U.S. and in the European Union in the following presentations: a 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for injection and a 130 mg/26 mL (5 mg/mL) single dose vial for IV infusion. Otulfi® in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA and EMA approval in the first half of 2025.
1) Otulfi® ist eine eingetragene Marke von Fresenius Kabi Deutschland GmbH in ausgewählten Ländern
2) Stelara® ist eine eingetragene Marke von Johnson & Johnson