EQS-News: Formycon and Fresenius Kabi reach settlement agreement for ustekinumab biosimilar candidate FYB202 in Europe and Canada
EQS-News: Formycon AG
/ Key word(s): Agreement
Press release // March 18, 2024
Formycon and Fresenius Kabi reach settlement agreement for ustekinumab biosimilar candidate FYB202 in Europe and Canada Munich, Germany – Formycon AG (FSE: FYB) and its commercialization partner Fresenius Kabi today announced the signing of a settlement agreement with Johnson Johnson concerning the commercialization of FYB202, a biosimilar to Stelara®1 (ustekinumab), in Europe and Canada. It was agreed to keep the terms of the agreement confidential. Nicola Mikulcik, Chief Business Officer of Formycon AG, commented: "Achieving this settlement is testament to our strategic approach of ensuring we make early preparations to expand patient access to critical treatments. Our aim is to make a significant difference in patients' lives by providing them with reliable, high-quality, and affordable treatment options. Following the settlement for the US, this is another important step that underlines the joint effort of Formycon and Fresenius Kabi, and it solidifies our position to make FYB202 accessible in key global markets.” FYB202 is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 and is used for the treatment of various severe immune-mediated disorders. Stelara® is approved for the treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis. The marketing authorization application for FYB202 was accepted for review by the European Medicines Agency (EMA) in September 2023 and by the U.S. Food and Drug Administration (FDA) in November 2023. In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement for the ustekinumab biosimilar candidate FYB202, under which FYB202 will be marketed by Fresenius Kabi in key global markets following successful approval. 1) Stelara® is a registered trademark of Johnson Johnson. About Formycon: About Fresenius Kabi: For more information visit the Fresenius Kabi’s website at www.fresenius-kabi.com
Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare providers. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.
Formycon AG Disclaimer:
18.03.2024 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: | 1860459 |
End of News | EQS News Service |
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1860459 18.03.2024 CET/CEST
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