Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM

Formycon AG and its commercialization partner Fresenius Kabi jointly said Monday that the U.S. Food and Drug Administration (FDA) has approved FYB202/OtulfiTM1 (ustekinumab-aauz), a biosimilar to Stelara, for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis, the third Formycon biosimilar successfully approved by the FDA.

In February 2023, Formycon and Fresenius Kabi entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202 in key global markets, including the U.S.

Dr. Stefan Glombitza, CEO of Formycon AG, said this marks company’s second FDA approval this year. He said that the company’s ustekinumab biosimilar FYB202 exemplifies Formycon´s technical expertise and capabilities in developing high-quality, safe and affordable biologics. Furthermore, particularly in the area of chronic inflammatory diseases, only a limited number of patients worldwide have access to biologic therapies or often have to wait for years to receive this highly effective treatment. It is important to us to improve access to biosimilars as quickly and broadly as possible, he said.

Glombitza said that FYB202 represents a key pillar of Formycon’s commercial and financial development going forward. He said that it allows our biosimilar to enter the market earlier than previously announced, improving the company’s competitive positioning even further.

Enno Spillner, CFO of Formycon AG, added: “The U.S. approval is an important step on our path to sustainable profitability, since FYB202 will contribute strongly to the financial strength of Formycon. We are pleased that with the recent approval decisions of the European Commission and the FDA, we have now successfully completed the formal approval process of FYB202 for the major markets.“

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, said: “The FDA approval of FYB202, Fresenius Kabi’s fourth biosimilar product in the US market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the US and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally.”

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). With global sales of more than USD 10 billion in 20233, Stelara® is one of the best-selling immunological drugs. The U.S. market accounted for the largest share of these sales at around USD 6 billion.