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

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

Disclaimer
Certain statements contained in this release may constitute "forward-looking statements" that involve a number of risks and uncertainties. Forward-looking statements can generally be identified by the use of the words "may," "will," "should," "plan," "expect," "anticipate," "estimate," "believe," "intend," "project," or "aim," or the negative of these words or other variations of these words or comparable terminology. Forward-looking statements are based on assumptions, forecasts, estimates, projections, opinions or plans that, by their nature, are subject to significant risks and uncertainties and contingencies that are subject to change.

Formycon does not and will not give any assurance that any forward-looking statement will be achieved or prove to be accurate. Actual future business, financial condition, results of operations and prospects may differ materially from those projected or anticipated in the forward-looking statements. Subject to applicable legal requirements, neither Formycon nor any other person intends to update, review, revise or revise any forward-looking statements in this release to reflect actual events or developments, whether as a result of new information becoming available, new developments occurring in the future or otherwise, nor does it undertake any such obligation.