Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Biologics License Application (“BLA”) for FYB202, a proposed biosimilar candidate to Stelara®1.

FYB202 is a human monoclonal antibody that targets interleukin 12 and interleukin 23 for the treatment of immune-mediated disorders. The reference medicinal product Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis.

“The FDA file acceptance for our Stelara® biosimilar candidate FYB202 underlines the great expertise and capabilities of #TeamFormycon. Following the acceptance of our application by the EMA at the end of September, this represents another major step for us towards providing a high-quality, safe and affordable treatment option for patients with severe chronic inflammatory diseases. Thus, we are right on track with all important milestones we wanted to achieve in 2023,” says Formycon CEO Dr. Stefan Glombitza.

“Today’s BLA submission acceptance underscores Fresenius Kabi and Formycon’s unwavering commitment to improving patient access to high-quality biopharmaceuticals worldwide and to bring the ustekinumab biosimilar candidate FYB202 one step closer to patients and healthcare providers in the United States. In line with our Vision 2026, we remain dedicated to advancing healthcare solutions for the benefit of patients while expanding our immunology & oncology portfolio.“, says Dr. Michael Schönhofen, President Fresenius Kabi Biopharmaceuticals


1) Stelara® is a registered trademark of Johnson & Johnson