The product candidate in our development pipeline closest to completion is FYB201, a candidate biosimilar to the blockbuster ophthalmic drug ranibizumab (reference product: Lucentis®)*
Current development status
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. 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.
Ranibizumab is, along with aflibercept, among the most widely used anti-vascular endothelial growth factor (VEGFs) today. In 2022, Lucentis® generated global sales of around USD 2.9 billion.
In the EU, the US and UK FYB201 is approved for the treatment of all five Lucentis® indications.
Following the approval by the UK Medicines and Healthcare Regulatory Agency (MHRA) on May 17, 2022 for the United Kingdom, the U.S. Food and Drug Administration (FDA) approved FYB201 on August 02, 2022 as the first and only biosimilar interchangeable with Lucentis® in the United States. Approval by the European Commission followed on August 26, after the EMA’s Committee for Medicinal Products for Human Use (CHMP) had already published a positive opinion on FYB201 in June.
In the United Kingdom, the biosimilar was already launched in July 2022 by Teva Pharmaceutical Industries Ltd. (Teva) under the name ONGAVIA®***. In the 27 member states of the European Union as well as Iceland, Norway and Liechtenstein, the launch by Teva under the name Ranivisio®**** is taking place successively. In the United States, the Lucentis® biosimilar has been available through Coherus BioSciences, Inc. under the trade name CIMERLI™** since October 2022.
Submission of marketing authorization applications for FYB201 in other attractive markets is planned over the coming months. In this context, MS Pharma will commercialize FYB201 in the Middle East and North Africa (MENA) region following approval by the relevant regulatory authorities.
* Lucentis® is a registered trademark of Genentech, Inc.
** CIMERLI™ is a trademark of Coherus BioSciences, Inc.
*** ONGAVIA® is a registered trademark of Teva Pharmaceutical Industries Ltd.
**** RANIVISIO® is a registered trademark of Bioeq AG