Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA

Formycon AG / Key word(s): Statement/Regulatory Admission
Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA

15-Nov-2024 / 18:18 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News - a service of EQS Group AG.
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Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014
 

Aflibercept-Biosimilar FYB203 / AHZANTIVE^®/ Baiama^® receives positive CHMP Opinion from EMA
 

Planegg-Martinsried, Germany, November 15, 2024 – Formycon (FSE: FYB, "Formycon“) announces that the European Medicines Agency (EMA) published today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for market approval for FYB203/ AHZANTIVE^®1/ Baiama^®2, a biosimilar candidate to Eylea^®3 (Aflibercept).

FYB203 has thus been recommended for approval in the European Union (EU) for the treatment of adult patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Oedema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Oedema following Retinal Vein Occlusion (RVO). The CHMP's scientific assessment report forms the basis for the European Commission's decision to grant a central marketing authorization, which is expected in the second half of January 2025.

The CHMP recommendation for FYB203 / AHZANTIVE^®/ Baiama^® is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB203 / AHZANTIVE^®/ Baiama^® demonstrated comparable quality, efficacy, safety and immunogenicity to the reference drug Eylea^® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD).

1) AHZANTIVE^® is a registered Trademark of Klinge Biopharma GmbH
2) Baiama^® is a registered Trademark of Klinge Biopharma GmbH
3) Eylea^® is a registered Trademark of Regeneron Pharmaceuticals Inc.
 

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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