NANOHALE AG (FRA:FYB) FYB201, Formycon's Biosimilar for Lucentis®1 achieves Marketing Authorization in United Kingdom
Transparency directive : regulatory news
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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 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 Biosimilars:
17-May-2022 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
| 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 |
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1354635 17-May-2022 CET/CEST