DGAP-Adhoc: Formycon announces EU-Approval of FYB201/Ranivisio®1 a biosimilar to Lucentis®2

2022. augusztus 26., péntek, 16:05





DGAP-Ad-hoc: Formycon AG / Key word(s): Regulatory Approval


Formycon announces EU-Approval of FYB201/Ranivisio®1 a biosimilar to Lucentis®2


26-Aug-2022 / 16:05 CET/CEST


Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG.


The issuer is solely responsible for the content of this announcement.




 



Publication of insider information in accordance with Article 17 of the Regulation (EU) No 596/2014 Ad Hoc Announcement // August 26, 2022



Formycon announces EU-Approval of FYB201/Ranivisio®1 a biosimilar to Lucentis®2



Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that the European Commission (“EC”) today has granted marketing authorization (“MA”) for Ranivisio®, a biosimilar to Lucentis® (ranibizumab-injection) for medical use in the European Union (“EU”).



FYB201/Ranivisio® was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. Mid 2021, Teva Pharmaceutical Industries Ltd. (“Teva”) entered into a strategic partnership for the exclusive commercialization of FYB201 under the brand name Ranivisio® in the EU. The commercial launch of Ranivisio® in the EU is planned as soon as possible.



The European Commission now followed the positive opinion issued by the Committee for Medicinal Products for Human Use ("CHMP") in June 2022 and approved Ranivisio® for the treatment of  neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR) as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).



The EU-approval is based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS-AMD) it was shown that Ranivisio® is highly similar to the reference product Lucentis® in terms of comparable efficacy, safety, pharmacokinetics and immunogenicity in patients with age-related neovascular (wet) macular degeneration.



1) Ranivisio® is a registered trademark of Bioeq AG
2
) Lucentis® is a registered trademark of Genentech Inc.



 



About Formycon:

Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. Formycon AG is listed in the Open Market ("Scale") of the Frankfurt Stock Exchange (ISIN: DE000A1EWVY8 / WKN: A1EWVY).



About Biosimilars:

Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.



Contact:

Sabrina Müller

Senior Manager Corporate Communications and Investor Relations

Formycon AG

Fraunhoferstr. 15

82152 Martinsried/Planegg/Germany

phone +49 (0) 89 - 86 46 67 149

fax + 49 (0) 89 - 86 46 67 110
[email protected] // www.formycon.com











26-Aug-2022 CET/CEST The DGAP 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: 1429485





 
End of Announcement DGAP News Service




1429485  26-Aug-2022 CET/CEST







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