EQS-News: Formycon AG / Key word(s): Statement/Regulatory Admission Formycon and Fresenius Kabi receive positive CHMP opinion for FYB202 (Ustekinumab), a biosimilar candidate to Stelara® 26.07.2024 / 12:00 CET/CEST The issuer is solely responsible for the content of this announcement. Press Release // July 26, 2024 Formycon and Fresenius Kabi receive positive CHMP opinion for FYB202 (Ustekinumab), a biosimilar candidate to Stelara®
Planegg-Martinsried, Germany – Formycon AG (FWB: FYB) and its commercialization partner Fresenius Kabi jointly announce, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB202, a biosimilar candidate to Stelara®1 (Ustekinumab) indicated for the treatment of several serious inflammatory diseases. Dr. Stefan Glombitza, CEO of Formycon AG, commented: „The CHMP recommendation for FYB202, our biosimilar candidate to Stelara®, is an important prerequisite for approval by the European Commission. With FYB202, more patients with serious chronic inflammatory diseases will have access to high-quality and affordable therapies. This recommendation is an additional confirmation of our great expertise in development and in the regulatory area. Economically, the Stelara® biosimilar is expected to significantly increase Formycon revenues following its global launch and thus contribute to sustainable EBITDA profitability in the medium term.“ Within the approval process, the CHMP’s positive opinion represents an important regulatory step towards the approval of FYB202 in the European Union. The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization valid in all EU member states, which is expected until early Q4 2024. Ustekinumab, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, is used to treat various severe inflammatory conditions. FYB202/Ustekinumab has been recommended by the CHMP for approval in the European Union (EU) for the treatment of serious inflammatory diseases in the fields of gastroenterology, dermatology, and rheumatology. The recommendation is based on a thorough evaluation of our 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 commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. 1Stelara® is a registered trademark of Johnson & Johnson
About Formycon: 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
About Biosimilars: Contact: Tel.: +49 (0) 89 – 86 46 67 149
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26.07.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
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: | 1954521 |
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