DGAP-Adhoc: FYB201, Formycon"s Biosimilar for Lucentis®1 achieves Marketing Authorization in United Kingdom

2022. május 17., kedd, 15:00





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


FYB201, Formycon"s Biosimilar for Lucentis®1 achieves Marketing Authorization in United Kingdom


17-May-2022 / 15:00 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 // May 17, 2022



FYB201, Formycon"s Biosimilar for Lucentis®1 achieves Marketing Authorization in United Kingdom



Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce, that today the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) in the United Kingdom (“UK”) for FYB201, a biosimilar to Lucentis® (ranibizumab).



Lucentis® is used in the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.



The commercial launch of FYB201 in the UK by Teva Pharmaceutical Industries Ltd. ("Teva"), which has licensed the distribution rights from Bioeq under an exclusive strategic partnership, is expected to follow as soon as possible. FYB201 will be marketed in the UK under the brand name ONGAVIA® and targets to be the first available Biosimilar for Lucentis® in Europe.



1)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
Sabrina.Mueller@formycon.com // www.formycon.com











17-May-2022 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de



























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: 1354635





 
End of Announcement DGAP News Service




1354635  17-May-2022 CET/CEST







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