• Otulfi® approved by Health Canada for both subcutaneous and intravenous formulations to treat serious inflammatory diseases
  • Health Canada joins the FDA and the European Commission in granting regulatory approval for FYB202
  • The earliest date for commercialization of Otulfi® in Canada 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 Health Canada has issued a “Notice of Compliance” (NOC) for FYB202/Otulfi®1 (ustekinumab), a biosimilar to Stelara®2. This approval applies to subcutaneous and intravenous formulations for the treatment of adult patients with moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. Both the U.S. Food and Drug Administration (FDA) and the European Commission had already granted marketing authorization for FYB202 in September 2024.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “We are extremely pleased to receive Health Canada’s approval for our ustekinumab biosimilar. Canada was one of the world’s highest per-capita spenders on biologics and has taken significant steps in recent years to promote biosimilar adoption. These initiatives have proven highly effective in driving biosimilar uptake3, supporting our mission to improve patient access to essential medicines while reducing healthcare costs. Together with our partner Fresenius Kabi, we look forward to making a meaningful contribution to Canada’s healthcare system.”

In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement granting Fresenius Kabi commercialization rights for FYB202 in key global markets, including Canada. In accordance with the confidential terms of the settlement agreement with Johnson & Johnson, Fresenius Kabi intends to launch the biosimilar in Canada at the agreed time.

Ustekinumab is a human monoclonal antibody targeting the cytokines interleukin-12 and interleukin-23, which play an important role in inflammatory and immune responses. Health Canada’s approval was based on comprehensive analytical, preclinical, clinical, and manufacturing data demonstrating that FYB202 is highly comparable to Stelara® in efficacy, safety, and pharmacokinetics. The pivotal clinical study included patients with moderate to severe plaque psoriasis (psoriasis vulgaris).

This approval underscores Formycon’s commitment to expanding access to high-quality biosimilars worldwide, reinforcing its position as a global leader in the development of biosimilar medicines.

 


 

1) Otulfi® is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
2) Stelara® is a registered trademark of Johnson & Johnson
3) https://www.canada.ca/content/dam/pmprb-cepmb/documents/npduis/analytical-studies/posters/2023/biosimilars-policies-promote-switching.pdf