DGAP-Ad-hoc: Formycon AG / Key word(s): Regulatory Approval
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
26-Aug-2022 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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1429485 26-Aug-2022 CET/CEST