The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Fresenius Kabi and Formycon’s ustekinumab biosimilar candidate, indicated for the treatment of several serious inflammatory diseases. Fresenius Kabi is further continuing its momentum with Otulfi after receiving marketing authorisations in Europe and in the US in September 2024.
“This is Fresenius Kabi’s third immunology biosimilar product approval, an important milestone on our pathway to expand our biopharma portfolio in the UK. This achievement underscores our commitment to improving patient care across the country,” said Darius Panaligan Sr. Vice President Commercial, Fresenius Kabi Biopharma, EU & ROW.
In February 2023, Fresenius Kabi and Formycon entered into a global commercialisation partnership for the ustekinumab biosimilar candidate covering key global markets. In March 2024, Formycon and Fresenius Kabi reached a settlement agreement with Johnson & Johnson concerning the commercialization of their ustekinumab biosimilar in Europe (including the UK) and Canada.
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. FYB202 (Otulfi) demonstrated comparable efficacy, safety and pharmacokinetics to the reference product Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). Fresenius Kabi received MHRA approval for both subcutaneous and intravenous formulations.
“We are very proud to be introducing an affordable alternative ustekinumab treatment option for patients living with these challenging inflammatory and immune diseases,” said Fabio Kellett, Head of Commercial, Biopharmaceuticals, UK, Ireland & Nordics.
