DGAP-Ad-hoc: Formycon AG / Key word(s): Regulatory Approval/Interim Report
FYB201, Formycon's biosimilar for Lucentis® (ranibizumab), receives CHMP recommendation from EMA
Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") announce that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") today issued a positive opinion for FYB201, a biosimilar to Lucentis®1.
FYB201 has thus been recommended for approval in the European Union (EU) for the treatment of patients with age-related neovascular (wet) macular degeneration (AMD) and other serious ocular diseases such as diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), macular edema due to retinal vein occlusion (branch RVO or central RVO) and choroidal neovascularization (CNV).
The CHMP recommendation is based on an in-depth evaluation of a comprehensive set of data for comparative analytical characterization and commercial-scale manufacturing. In a randomized, double-blind, multicenter, parallel-group Phase III study, FYB201 also demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Lucentis® (ranibizumab) in patients with age-related neovascular (wet) macular degeneration.
Within the approval process, the CHMP's favorable opinion represents an important regulatory step towards the approval of FYB201 in the European Union. The CHMP's scientific assessment report forms the basis for the European Commission's decision to grant a central marketing authorization, which is expected at the end of August.
Teva Pharmaceutical Industries Ltd.has licensed the distribution rights under an exclusive strategic partnership from Bioeq for Europe and other territories and is currently preparing the launch of FYB201 in Europe.
1)Lucentis® is a registered trademark of Genentech Inc.
24-Jun-2022 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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1383617 24-Jun-2022 CET/CEST