Formycon AG
Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi® (ustekinumab) for the treatment of serious inflammatory diseases
EQS-News: Formycon AG
/ Key word(s): Regulatory Approval/Miscellaneous
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Kabi jointly announce that the European Commission (EC) has issued a marketing authorization for FYB202/Otulfi®1, a biosimilar to Stelara®2. The centralized marketing authorization is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway. 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 European Commission’s decision to issue a marketing authorization came after the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency’s (EMA) adopted a positive opinion in July 2024 to approve FYB202/Otulfi® in the indications of moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis. The EC decision 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). In February 2023, Formycon and Fresenius Kabi entered into a global license agreement providing Fresenius Kabi with commercialization rights for FYB202 in key global markets. Semi-exclusive commercialization rights that cover Germany, parts of the MENA region and Latin America remain with Formycon. In March 2024, Formycon and Fresenius Kabi reached a settlement agreement with Johnson & Johnson concerning the commercialization of their ustekinumab biosimilar in Europe and Canada. The terms of the agreement are confidential. Stelara® ranks among Europe’s top-10 medicine brands by value with annual sales in Europe in excess of €2.5 billion. Dr. Stefan Glombitza, CEO of Formycon AG, said: “FYB202/ustekinumab is our second biosimilar with market approval in Europe, and this marks another very important step on our way to a leading, profitable and sustainable pure-play biosimilar company. Chronic inflammatory diseases are globally on the rise and negatively impact the quality of life of millions of people. This especially relates to Europe, which has the highest prevalence of psoriatic diseases in the world.3 With FYB202/Otulfi® we are – together with our partner Fresenius Kabi – committed to providing a safe, effective and cost-efficient treatment option for this large number of patients.” Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, said: “With the approval of Otulfi® in Europe, we expand our biosimilar portfolio with the fourth biosimilar to better support patients’ treatment experience and clinical outcomes. Our ustekinumab biosimilar is a testament to our dedication and commitment to patients across Europe, and we are proud to continue to deliver high-quality and affordable therapies for autoimmune diseases, while striving to ease the burden on local healthcare systems.” About Formycon: About Biosimilars: About Fresenius Kabi: Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. For more information visit the Fresenius Kabi’s website at www.fresenius-kabi.com. For more information about the company’s work in biosimilars, please visit https://biosimilars.fresenius-kabi.com Contact: Tel.: +49 (0) 89 – 86 46 67 149
27.09.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG. |
Language: | English |
Company: | Formycon AG |
Fraunhoferstraße 15 | |
82152 Planegg-Martinsried | |
Germany | |
Phone: | 089 864667 100 |
Fax: | 089 864667 110 |
Internet: | www.formycon.com |
ISIN: | DE000A1EWVY8 |
WKN: | A1EWVY |
Indices: | Scale 30 |
Listed: | Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Hamburg, Munich, Stuttgart, Tradegate Exchange |
EQS News ID: | 1996625 |
End of News | EQS News Service |