Health Canada Approves Formycon's Biosimilar FYB202/Otulfi®

Formycon AG, along with Fresenius Kabi Canada, has received Health Canada's approval for FYB202/Otulfi®, a biosimilar to Stelara®. This authorization covers both subcutaneous and intravenous forms for treating inflammatory diseases such as Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis in adults.

Previously, the U.S. FDA and the European Commission had granted approval for FYB202 in September 2024. A confidential agreement with Johnson & Johnson determines the commercialization timeline in Canada. The biosimilar targets cytokines interleukin-12 and interleukin-23, with trials confirming its similarity to Stelara® in efficacy and safety.

This milestone highlights Formycon's commitment to expanding biosimilar access globally, aiming to reduce healthcare costs while improving patient access to essential treatments.