Formycon AG and its licensing partner Bioeq AG announced that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") issued a positive opinion for FYB201, a biosimilar to Lucentis. 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.