Stelara® Biosimilar Candidate FYB202 (Ustekinumab) receives positive CHMP opinion from EMA

Formycon AG / Key word(s): Statement/Regulatory Admission
Stelara® Biosimilar Candidate FYB202 (Ustekinumab) receives positive CHMP opinion from EMA

26-Jul-2024 / 10:54 CET/CEST
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Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014

Stelara^® Biosimilar Candidate FYB202 (Ustekinumab) receives positive CHMP opinion from EMA

Planegg-Martinsried, Germany, July 26, 2024 – Formycon AG (FSE: FYB, "Formycon“) announces that the Committee for Medicinal Products for Human Use („CHMP“) of the European Medicines Agency („EMA“) today issued a positive opinion for FYB202, a biosimilar candidate to Stelara^®1 (Ustekinumab).

FYB202 has thus been recommended for approval in the European Union (EU) for the treatment of serious inflammatory diseases in the fields of gastroenterology, dermatology and rheumatology. The CHMP's scientific assessment report forms the basis for the European Commission's decision to grant a central marketing authorization, which is expected until early Q4 2024.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 and is used to treat various severe inflammatory diseases. The CHMP recommendation 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).

¹⁾ Stelara^® is a registered trademark of Johnson & Johnson
 

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

phone +49 (0) 89 – 86 46 67 149
fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com
www.formycon.com

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