Formycon and bioeq enroll first patient in pivotal phase III study with biosimilar ranibizumab (FYB201)

Munich – Formycon AG, Munich, and bioeq GmbH, Holzkirchen, today announced that they have enrolled the first patient in their clinical Phase III study involving FYB201, Formycon’s biosimilar version of Lucentis®. The objective of the study is to demonstrate the comparability of FYB201 and Lucentis® in terms of safety, effectiveness, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD). This condition, known as wet AMD, is one of the primary causes of loss of vision in people over the age of 60 in developed countries. It is estimated that as many as 7.5 million people worldwide suffer from wet AMD. Germany alone has around 450,000 patients with the condition.

Lucentis® is a leading drug for the treatment of neovascular age-related macular degeneration. It inhibits the vascular endothelial growth factor (VEGF) responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. The total market volume for intraocular anti-VEGF treatments in 2015 was around US$ 7.5 billion, and is growing rapidly.

Dr. Björn Capsius, Director Clinical Development at Formycon, said: “We are delighted that, after intensive preparations, our study has now started to enroll its first patient. It is a major step forward in the development of our biosimilar and we will gain important data supporting the regulatory approval in the EU and US.”

Dr. Joachim Kiefer, Head of Clinical Development at bioeq, added: “The active ingredient ranibizumab is an effective and proven therapy for the treatment of age-related macular degeneration. By developing a high-quality and cost-effective biosimilar, we want to give as many patients as possible the opportunity to access this treatment option. This not only helps improve patient care, but also helps to reduce healthcare costs.”

At the end of 2013, Formycon licensed FYB201 exclusively to Santo Holding GmbH, Holzkirchen. bioeq GmbH, a subsidiary of Santo Holding GmbH, is the sponsor of the Phase III study and is also responsible for the global marketing and licensing of FYB201.

* Lucentis is a registered trademark of Genentech Inc.