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EQS-Ad-hoc: Formycon AG / Key word(s): Regulatory Approval
FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb)
28-Jun-2024 / 23:50 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News
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Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014
FDA grants approval for Eylea^®^1) biosimilar FYB203/AHZANTIVE^®2) (aflibercept-mrbb)
Planegg-Martinsried, Germany, 28. June 2024 - Formycon AG (FSE: FYB, "Formycon") and its licensing partner Klinge
Biopharma GmbH ("Klinge") announce that the U.S. Food and Drug Administration ("FDA") today approved FYB203/AHZANTIVE^®
(aflibercept-mrbb), a biosimilar to Eylea^®.
FYB203/AHZANTIVE^® obtained FDA approval for the treatment of patients with neovascular Age-Related (wet) Macular
Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR)
and Macular Edema following Retinal Vein Occlusion (RVO).
The approval for FYB203/AHZANTIVE^® is based on a thorough evaluation of a comprehensive data package including
analytical, pre-clinical, clinical and manufacturing data. FYB203/AHZANTIVE^® demonstrated comparable efficacy, safety,
pharmacokinetics and immunogenicity to the reference drug Eylea^® in patients with neovascular Age-Related (wet)
Macular Degeneration (nAMD).
^1) Eylea^® is a registered Trademark of Regeneron Pharmaceuticals Inc.
^2) AHZANTIVE^® is a registered Trademark of Klinge Biopharma GmbH
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.
End of Inside Information
28-Jun-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press
Releases.

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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: 1936195

End of Announcement EQS News Service
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1936195 28-Jun-2024 CET/CEST

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June 28, 2024 17:52 ET (21:52 GMT)