FYB203


Aflibercept biosimilar candidate

FYB203 is a biosimilar candidate to Eylea®* (active ingredient: aflibercept). Like Lucentis®, Eylea® is used in the treatment of neovascular age-related macular degeneration (nAMD), along with several other serious eye diseases.

Reference

Eylea®


Indication

Ophthalmology


Partner

Klinge Biopharma GmbH


Current development status

Preclinical phase
Clinical phase III

Scope of therapeutic indication


Aflibercept is a recombinant human fusion protein which works by binding to vascular endothelial growth factor (VEGF-A), as well as to placental growth factor (PLGF). Through this action, aflibercept suppresses the formation of blood vessels in the retina, which otherwise impair vision. Like Lucentis®, Eylea® is injected directly into the vitreous body of the eye.

Due to their different mechanisms of action, aflibercept and ranibizumab complement each other very well in clinical practice. Some patients respond better to aflibercept, while others see more benefit from ranibizumab. Our two biosimilar drugs in this area seek to provide patients with better access to effective treatment with high-quality biopharmaceuticals by offering more cost effective treatment options to ophthalmologists.


Our development work


The preclinical study with FYB203 in an alternative formulation was able to demonstrate comparable intraocular pharmacokinetics to the reference product. In addition, we have largely completed the development of an efficient process to manufacture the drug. As with FYB201, we are also working on our own proprietary application system for administering this drug within the eye.

In May 2015, we signed a deal to out-license FYB203 to Santo Holding (Deutschland) GmbH, which transferred the worldwide marketing rights for FYB203 within the Santo Group to Klinge Biopharm GmbH. As with FYB201, we will participate in any potential future product revenue.


The market


Together, aflibercept and ranibizumab make up more than 90 percent of the world market for anti-VEGF therapies, which generated 2019 full-year revenue of approx. USD 11.4 billion. In 2019, Eylea® alone generated some USD 7.5 billion in sales, with strong growth in market volume. Compared to 2018, sales increased by approximately 12 percent.

Demographics are a key long-term driver of this growth because, as people grow older, so does the spread of age-related eye diseases and thus the demand for effective treatment options.


Next milestones

The start of the phase III clinical trial has been announced in August 2020. The aim of the clinical study is to demonstrate the comparability of FYB203 and the reference product Eylea® in terms of efficacy, safety and immunogenicity in patients with neovascular age-related macular degeneration (nAMD).. Should these trials proceed according to plan, our partner should be able to launch FYB203 in the United States and the European market, when patent protection for the reference product expires.


* Eylea is a registered trademark of Regeneron Pharmaceuticals, Inc.