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.

About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207.

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 2025, 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.