Formycon starts phase III trial for ranibizumab biosimilar

Biosimilars/News | Posted 13/11/2015 post-comment0 Post your comment

German biosimilars companies Formycon and Bioeq announced on 7 October 2015 that they had initiated a pivotal phase III clinical trial with their candidate ranibizumab biosimilar (FYB201).

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The global clinical trial is designed to confirm biosimilarity with respect to safety, efficacy and immunogenicity of FYB201 versus blockbuster eye drug Lucentis in patients with neovascular age-related macular degeneration (nAMD). The study design was developed in consultation with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is expected to support registration in both regions. 

Ranibizumab inhibits vascular endothelial growth factor (VEGF) which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The current total market size for intraocular anti-VEGF therapy is estimated to be about US$6.9 billion.

The originator biological, blockbuster wet AMD treatment Lucentis (ranibizumab) from Novartis, had estimated global sales of approximately US$4 billion in 2014. The patents on Lucentis expire in Europe in 2022 and in the US in June 2020 [1].

Formycon licensed FYB201 exclusively to German investment firm Santo Holding in December 2013 [2]. Bioeq, an affiliate of Santo Holding, is acting as the sponsor of the phase III study and will also be responsible for the global commercialization and licensing of FYB201.

Formycon has also out-licensed its second candidate biosimilar FYB203 to Santo Holding. The company plans to develop its third candidate biosimilar (FYB202), which is currently at the preclinical stage, to the end of phase I clinical trials on its own. This product is expected to be out-licensed in 2018 [2].

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1.   GaBI Online - Generics and Biosimilars Initiative. Biological patent expiries []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 13]. Available from:
2.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars licensing agreements for AMP and Formycon []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 13]. Available from:

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Source: Bioeq, Formycon

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