FDA Approves Formycon and Fresenius Kabi's FYB202/Otulfi (ustekinumab-aauz)

Formycon AG and Fresenius Kabi have announced that the U.S. Food and Drug Administration (FDA) has approved their biosimilar FYB202/Otulfi™ (ustekinumab-aauz) for various inflammatory diseases, including Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This biosimilar is designed to be similar to Stelara®, a well-established drug in the treatment of these conditions, and marks the third successful FDA approval for Formycon.

Earlier in February 2023, Formycon and Fresenius Kabi entered into a global licensing agreement that granted Fresenius Kabi the rights to commercialize FYB202 in key markets, including the United States. This collaboration aims to bring high-quality and affordable biologics to a broader range of patients, particularly in the field of chronic inflammatory diseases, where access to biologic therapies remains limited.

Dr. Stefan Glombitza, CEO of Formycon AG, expressed pride in achieving this milestone and emphasized the significance of making biosimilars more accessible. He highlighted that the approval of FYB202 aligns with the company’s plans and showcases their technical expertise in developing effective biologic treatments. The early market entry of this biosimilar is expected to enhance Formycon's competitive position.

Enno Spillner, CFO of Formycon AG, pointed out that the U.S. approval is a critical step towards sustainable profitability for the company. FYB202 is anticipated to significantly contribute to Formycon's financial strength, especially following the recent approval decisions from both the European Commission and the FDA.

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, acknowledged this approval as an essential milestone for Fresenius Kabi. The approval of FYB202 marks the company’s fourth biosimilar product in the U.S. market and aligns with their Vision 2026 growth strategy. Their commitment to expanding their biopharma portfolio is aimed at becoming a major player in the biopharmaceutical sector, providing critical treatment options globally.

Ustekinumab, the active ingredient in FYB202, is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, which are important in inflammatory and immune responses. The FDA’s approval was based on comprehensive data evaluating the biosimilar’s analytical, pre-clinical, clinical, and manufacturing aspects. FYB202 demonstrated similar efficacy, safety, and pharmacokinetics to Stelara® in patients with moderate to severe plaque psoriasis.

Stelara® has been a highly successful immunological drug, with global sales exceeding USD 10 billion in 2023. The U.S. market accounted for a significant portion of these sales, around USD 6 billion. The introduction of FYB202 is expected to create more competition in the market, potentially lowering costs and increasing patient access to these vital treatments.

Formycon AG, headquartered in Munich and listed on the Frankfurt Stock Exchange, is a leading developer of biosimilars, focusing on areas such as ophthalmology, immunology, and immuno-oncology. They have successfully brought other biosimilars to market in Europe and the U.S., with additional candidates in development. Their mission is to provide as many patients as possible with access to effective and affordable medicines.

Fresenius Kabi, a global healthcare company, specializes in lifesaving medicines and technologies for critical and chronic care. Their commitment to increasing efficiencies and improving access to high-quality healthcare is a key component of their Vision 2026 strategy, which aims to benefit patients, customers, and stakeholders worldwide.

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