EQS-Adhoc: FDA grants approval for Stelara® Biosimilar FYB202/OtulfiTM (ustekinumab-aauz)

Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014

FDA grants approval for Stelara^® Biosimilar FYB202/Otulfi^TM (ustekinumab-aauz)

Planegg-Martinsried, Germany, September 27, 2024 – Formycon AG (FSE: FYB, "Formycon“) announces that the U.S. Food and Drug Administration (“FDA”) today approved FYB202/Otulfi^TM1 (ustekinumab-aauz), a biosimilar to Stelara^®2.

FYB202/Otulfi^TM obtained FDA approval for the treatment of patients with Crohn’s disease, ulcerative colitis, moderate-to-severe plaque psoriasis and active psoriatic arthritis.

The approval for FYB202/Otulfi^TM is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202/Otulfi^TM demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

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¹⁾ Otulfi^TM is a Trademark of Fresenius Kabi Deutschland GmbH in selected countries
²⁾ 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.

1997803  27-Sep-2024 CET/CEST