Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
EQS-News: Formycon AG
/ Key word(s): Regulatory Admission
Press Release // November 30, 2023 Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Biologics License Application (“BLA”) for FYB202, a proposed biosimilar candidate to Stelara®1. FYB202 is a human monoclonal antibody that targets interleukin 12 and interleukin 23 for the treatment of immune-mediated disorders. The reference medicinal product Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis. “The FDA file acceptance for our Stelara® biosimilar candidate FYB202 underlines the great expertise and capabilities of #TeamFormycon. Following the acceptance of our application by the EMA at the end of September, this represents another major step for us towards providing a high-quality, safe and affordable treatment option for patients with severe chronic inflammatory diseases. Thus, we are right on track with all important milestones we wanted to achieve in 2023,” says Formycon CEO Dr. Stefan Glombitza. “Today’s BLA submission acceptance underscores Fresenius Kabi and Formycon’s unwavering commitment to improving patient access to high-quality biopharmaceuticals worldwide and to bring the ustekinumab biosimilar candidate FYB202 one step closer to patients and healthcare providers in the United States. In line with our Vision 2026, we remain dedicated to advancing healthcare solutions for the benefit of patients while expanding our immunology & oncology portfolio.“, says Dr. Michael Schönhofen, President Fresenius Kabi Biopharmaceuticals
1) Stelara® 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. With its corporate mission of "caring for life", 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 “Vision 2026”, 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, please visit www.fresenius-kabi.com. About Biosimilars: Contact: Disclaimer:
30.11.2023 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: | 1784669 |
End of News | EQS News Service |
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