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 AG


Current development status

Preclinical phase
Clinical phase III
Submission
Approval

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. According to the UN, 20 to 25 million people worldwide are affected, and approximately 500,000 new cases are diagnosed each year. Estimates suggest that the number of cases could grow to around 70 million worldwide in the next 30 years.

In Germany alone, 4.5 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 (Deutschland) GmbH in 2013. Polpharma Biologics Group B.V., 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 AG, to which FYB201 was transferred. In 2022, Formycon acquired Santo Holding (Deutschland) GmbH’s respectively ATHOS KG’s 50 percent share in Bioeq AG in a transaction and thus holds half of the project and commercialization rights to FYB201.

Global phase III clinical trials (COLUMBUS-AMD) of FYB201 were initiated in early 2016, under the direction and responsibility of Bioeq 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 2021, Lucentis® generated global sales of around USD 3.6 billion.


Approval

On May 17, 2022, the UK Medicines and Healthcare Regulatory Agency (MHRA) became the first regulatory authority to give the green light for FYB201 in the United Kingdom. Thereby FYB201 is expected to be the first biosimilar to Lucentis® to be marketed in Europe.

With the positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the EMA on June 24, 2022, a further important step towards approval in Europe has been achieved. The subsequent decision of the European Commission and the associated EU approval of FYB201 is expected this summer. The approval process with the U.S. Food and Drug Administration (FDA) continues to proceed as planned with a target action date of August 2, 2022.

FYB201 will be marketed by Teva Pharmaceutical Industries Ltd. in the United Kingdom under the name Ongavia®**. If approved by the FDA on August 2, 2022, U.S. partner Coherus BioSciences, Inc. plans to launch FYB201 under the trade name CIMERLI™*** in the second half of 2022. In addition, MS Pharma will distribute FYB201 in the Middle East and North Africa (MENA) region upon approval by the relevant regulatory authority.


* Lucentis is a registered trademark of Genentech, Inc.
** Ongavia is a registered trademark of Teva Pharmaceutical Industries Ltd.
*** CIMERLI™ is a trademark of Coherus BioSciences, Inc.