FYB201


Ranibizumab biosimilar candidate

The product candidate in our development pipeline closest to completion is FYB201, a candidate biosimilar to the blockbuster ophthalmic drug ranibizumab (reference product: Lucentis®)*

Reference

Lucentis®


Indication

Ophthalmology


Partner

Bioeq IP AG


Current development status

Preclinical phase
Clinical phase III

Scope of therapeutic indication


Ranibizumab is used in the treatment of various eye diseases in adults which cause damage to the retina, thereby impairing vision. In these diseases, a protein called vascular endothelial growth factor (VEGF) causes excessive blood vessels to form within the retina, resulting in a progressive loss of central vision. In many cases, this process leads to a severe visual impairment or even blindness.

Due to the increasing aging in our society, the proportion of the population affected by age-related macular degeneration (AMD) has increased significantly in over recent years and decades. Today, AMD is the leading cause of blindness in developed countries among people over 50. The disease causes 32 percent of new blindness, followed by glaucoma and diabetic retinopathy, each at 16 percent. Worldwide, at least 25 to 30 million people are affected, with some estimates ranging from 30 to 50 Million. Every year, some 500,000 new cases are added.

In Germany alone, some two million people suffer from age-related macular degeneration (AMD). In the advanced stage of the disease, a distinction is made between a dry and a wet form of macular degeneration, while around 10-15% of all AMD patients suffer from the more dangerous form of neovascular, age-related, respectively wet macular degeneration (nAMD). Here, proliferating pathological new blood vessels in the retina cause the faster progressive loss of central vision.

In this case ranibizumab plays an important role in the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Treatment with ranibizumab inhibits certain growth factors involved in the formation of new vessels, with the result that deterioration of visual performance can be slowed down or even stopped altogether.


Our development work

 


Following the achievement of key milestones in the development of our first biosimilar candidate, FYB201, we were able to sign a major out-licensing deal with Santo Holding GmbH in 2013. Polpharma SA, Poland’s largest pharmaceutical company, subsequently acquired a 50 percent stake in the project, then Santo Holding and Polpharma together established a joint venture entity, Bioeq IP AG, to which FYB201 was transferred.

Global phase III clinical trials of FYB201 were initiated in early 2016, under the direction and responsibility of Bioeq IP AG. The study, planned in close coordination with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), aims to prove the comparability of FYB201 with Lucentis® in patients with neovascular age-related macular degeneration (nAMD) in terms of safety, efficacy and immunogenicity. With the attainment of the study’s primary endpoint in May 2018, it has now been clinically demonstrated that the efficacy of FYB201 in patients with nAMD is comparable to that of Lucentis®.

In addition to the biosimilar medicine itself, we are also developing our own proprietary application system for administering the drug, which should help to further improve FYB201’s market position.


The market


Ranibizumab is, along with aflibercept, among the most widely used anti-vascular endothelial growth factor (VEGFs) today. In 2018, Lucentis® generated global sales of USD 3.7 billion, with revenue growth continuing at a significant rate.


Next milestones

Following the completion of Formycon’s technical-pharmaceutical development data packages, it is planned to submit them to the US Food and Drug Administration, along with the clinical development data evolved by bioeq. Another important requirement is the establishment of the commercial supply chain, which is managed by our license partner Bioeq IP AG. This is intended to create the conditions for our license partner to become the first company with a ranibizumab biosimilar to be launched on the market after the legal protection period of the reference product in the USA expires.


* Lucentis is a registered trademark of Genentech, Inc.