Fresenius Kabi and Formycon AG have announced regulatory approvals for Otulfi (ustekinumab), a biosimilar to Stelara, in both Canada and the United Kingdom. These approvals mark a significant step forward in expanding treatment options for patients with chronic inflammatory diseases.
Health Canada issued a Notice of Compliance (NOC) for Otulfi on January 8, 2025, approving both subcutaneous and intravenous formulations for adult patients. The UK Medicines and Healthcare products Regulatory Agency (MHRA) followed suit on January 15, 2025, granting approval for the same indications.
Therapeutic Indications
Otulfi is now approved for the treatment of several inflammatory conditions, including:
- Moderately to severely active Crohn's disease
- Moderately to severely active ulcerative colitis
- Moderate to severe plaque psoriasis
- Active psoriatic arthritis
These approvals align with the indications of its originator biologic, Stelara, providing a biosimilar alternative for a wide range of patients.
Clinical Development and Data
The regulatory decisions were based on a comprehensive data package that included analytical, preclinical, clinical, and manufacturing data. Studies demonstrated that Otulfi has comparable efficacy, safety, pharmacokinetics, and immunogenicity to Stelara in patients with moderate to severe plaque psoriasis. Ustekinumab, a human monoclonal antibody, targets the cytokines interleukin-12 and interleukin-23, which are key players in inflammatory and immune responses.
Strategic Implications
Dr. Stefan Glombitza, CEO of Formycon AG, emphasized the importance of these approvals, stating, "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."
The partnership between Formycon and Fresenius Kabi, established in February 2023, grants Fresenius Kabi commercialization rights for FYB202 (Otulfi) in key global markets, including Canada and the UK. Fresenius Kabi Canada also offers a patient support program (PSP), KabiCare, to provide tailored support to Canadian patients prescribed Otulfi, including injection training, reimbursement assistance, and lifestyle assessments.
Biosimilar Market and Cost-Effectiveness
The introduction of biosimilars like Otulfi is expected to drive down healthcare costs and improve patient access to essential medicines. Canada, in particular, has been proactive in promoting biosimilar adoption, with initiatives that have proven highly effective in driving uptake. As biosimilars gain wider acceptance, they are poised to revolutionize the treatment landscape for chronic inflammatory diseases, offering cost-effective alternatives to originator biologics.
