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
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 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. Within the framework of this participation model, we will participate in future product sales through corresponding royalties.
The market
Together, aflibercept and ranibizumab make up more than 90 percent of the world market for anti-VEGF therapies. In 2022, Eylea® alone generated some USD 9.5 billion in sales, with further growth in market volume.
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.
In early February 2023, Formycon published positive preliminary efficacy and safety data from MAGELLAN-AMD Phase III clinical trial: The FDA-specific interim analysis of the randomized, double-blind, multi-center phase III study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB203 and the reference medicine Eylea® in patients with neovascular age-related macular degeneration (nAMD).
The submission of the Biologics License Application to the U.S. Food and Drug Administration (FDA) and the subsequent acceptance of the application (File Acceptance) has already been reported. The marketing authorization application was submitted to the European Medicines Agency (EMA) in November 2023.
* Eylea is a registered trademark of Regeneron Pharmaceuticals, Inc.