EC Approves FYB202/Otulfi® for Inflammatory Diseases

Formycon AG (FSE: FYB) and Fresenius Kabi have jointly announced that the European Commission (EC) has granted marketing authorization for FYB202/Otulfi, a biosimilar to Stelara. This centralized authorization is applicable across all European Economic Area (EEA) countries, which includes the 27 European Union (EU) member states, as well as Iceland, Liechtenstein, and Norway.

Ustekinumab, the active ingredient in FYB202, is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, which are crucial in inflammatory and immune responses. The approval from the European Commission followed a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2024. This recommendation was based on the efficacy of FYB202 in treating conditions such as moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis, and active psoriatic arthritis. The decision was supported by a comprehensive data package that included analytical, pre-clinical, clinical, and manufacturing data. FYB202 exhibited similar efficacy, safety, and pharmacokinetics to the reference drug Stelara in patients with moderate to severe plaque psoriasis.

In February 2023, Formycon and Fresenius Kabi forged a global license agreement that allowed Fresenius Kabi to commercialize FYB202 in key global markets. However, Formycon retained semi-exclusive commercialization rights for Germany, parts of the MENA region, and Latin America. Additionally, in March 2024, the companies settled a commercial dispute with Johnson & Johnson regarding the marketing of their ustekinumab biosimilar in Europe and Canada. The specifics of this agreement remain confidential. Stelara is one of the top-10 medicine brands in Europe by value, with annual sales surpassing €2.5 billion.

Dr. Stefan Glombitza, CEO of Formycon AG, noted that FYB202 marks the company's second biosimilar approved in Europe, highlighting a significant milestone towards establishing Formycon as a leading and sustainable biosimilar company. He emphasized the rising global incidence of chronic inflammatory diseases, which severely affect the quality of life for millions, particularly in Europe. Dr. Glombitza expressed commitment to offering a safe, effective, and affordable treatment for these diseases through FYB202/Otulfi, in partnership with Fresenius Kabi.

Dr. Sang-Jin Pak, President of Biopharma and a member of the Fresenius Kabi Management Board, expressed pride in expanding their biosimilar portfolio with the approval of Otulfi in Europe. He highlighted the company's dedication to enhancing patients' treatment experiences and clinical outcomes. Dr. Pak reiterated Fresenius Kabi's commitment to providing high-quality, affordable therapies for autoimmune diseases and alleviating the burden on healthcare systems.

Formycon AG is an independent developer of high-quality biosimilars, focusing on treatments in areas such as ophthalmology, immunology, and immuno-oncology. The company manages the entire value chain from technical development through to regulatory approval and relies on strong global partnerships for commercialization. Formycon's portfolio includes FYB201/ranibizumab, already available in Europe and the USA, FYB203/aflibercept-mrbb, approved by the FDA, and FYB202/ustekinumab, recently approved in Europe. With additional biosimilar candidates in development, Formycon aims to provide effective and affordable medical treatments to a broader patient base.

Fresenius Kabi, a global healthcare company specializing in critical care products and services, offers a diverse range of biopharmaceuticals, clinical nutrition, medical technologies, and generic drugs. The company is focused on improving patient care and access to high-quality healthcare, following its strategic "Vision 2026" plan. Fresenius Kabi aims to lead globally in its product segments, benefitting patients, customers, and stakeholders.