Aflibercept biosimilar candidate

FYB203 is a candidate biosimilar 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.






Santo Holding (Deutschland) 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. This usually takes place once a month during the initial treatment phase, followed by subsequent treatment in the case of nAMD or DME every two months.

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 development of FYB203 is currently in the advanced preclinical phase, meaning that we have already been able to analytically demonstrate the comparability of our product 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 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 2018 full-year revenue of approx. USD 10.4 billion. In 2018, Eylea® alone generated some USD 7 billion in sales, with strong growth in market volume: Within the United States, sales grew by 10 percent in 2018 over the prior year, while outside the U.S., growth was almost 16 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

Currently scientific advice briefing books are being prepared in order to align on the future strategy with both regulatory authorities (FDA and EMA). The preclinical study with FYB203 in an alternative formulation was able to demonstrate comparable intraocular pharmacokinetics to the reference product.The next stage will focus on the preparation of the phase III clinical trial. 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.