Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the European Medicines Agency (“EMA”) has accepted the Marketing Authorization Application (“MAA”) 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.

“With the current FYB202 submission we are very proud of having brought our third biosimilar pipeline candidate onto the regulatory pathway. The EMA acceptance of the marketing authorization application brings us one step closer to offering broader access to another affordable and important high-quality biosimilar treatment option for patients with chronic immune-mediated inflammatory diseases in Europe,” commented Dr. Stefan Glombitza, CEO of Formycon AG.

“Today marks another milestone in our journey towards advancing healthcare accessibility and the provision of high-quality, affordable treatment options to patients across Europe. The MAA acceptance for review of biosimilar candidate FYB202 is a testament to the dedication and expertise of our teams and the company’s Vision 2026 growth strategy. At Fresenius Kabi, we believe in the power of biosimilars to transform patient care and contribute to the sustainability of healthcare systems,” said Dr. Michael Schönhofen, Fresenius Kabi President Biopharma.

In February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize the proposed ustekinumab biosimilar (FYB202) in key global markets after successful regulatory approvals.

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