DGAP-Adhoc: FYB201, Formycon's biosimilar for Lucentis® (ranibizumab), receives CHMP recommendation from EMA

Publication of insider information in accordance with Article 17 of the Regulation (EU) No 596/2014 Ad Hoc Announcement // June 24, 2022

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.

About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. Formycon AG is listed in the Open Market ("Scale") of the Frankfurt Stock Exchange (ISIN: DE000A1EWVY8 / WKN: A1EWVY).

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 2020, 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.

Contact:
Sabrina Müller
Senior Manager Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
[email protected] // www.formycon.com