Munich – Formycon AG today has announced details on the second biosimilar product which is jointly developed with Santo Holding GmbH. FYB203 is a biosimilar candidate for Eylea® (aflibercept). This comprises the common development pipeline with the two most important and best-selling medications in the field of ophthalmology, FYB201 (biosimilar candidate for Lucentis®**) and FYB203.
Eylea® and Lucentis® are used for the treatment of neovascular age-related macular degeneration (neovascular AMD) and other serious eye conditions. Lucentis® generated revenues of approximately USD 3.5 billion in 2015, while Eylea® achieved an estimated market volume of more than USD 4 billion. Together, both products represent almost the entire global market volume for intraocular anti-VEGF treatments, one of the fastest growing therapeutic areas on the pharmaceutical market.
Formycon out-licensed FYB203 exclusively to Santo Holding GmbH in Holzkirchen in May 2015. Bioeq GmbH, a subsidiary of Santo Holding GmbH, will be responsible for the clinical development, the approval and the global marketing and licensing of FYB203. Both development programs will be developed in close coordination with the US Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA), and are striving towards approval in both regions.
Dr. Carsten Brockmeyer, CEO of Formycon AG: “The development of biosimilars for Lucentis® and Eylea® has made us pioneers in the area of opthalmology biosimilars with the two most important products in this field. We believe we are the only company with a Lucentis® biosimilar already in the pivotal Phase III clinical study. Our strong position is also underlined by the number of formulation and application patents we have already filed which gives us a further competitive advantage. It is our goal to launch our biosimilars on the market at day one after the patent on the reference product expires.”
“The anticipated significant market growth in ophthalmology means that the provision of safe and high quality medications in this area poses a significant challenge for the global health care systems. Through our biosimilars, we are striving to make a considerable contribution to the supply of as many patients as possible worldwide with these important pharmaceutical products”, added Dr. Nicolas Combé, CFO of Formycon AG.
* Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.
** Lucentis is a registered trademark of Genentech Inc.