In March 2021, Formycon confirmed the resubmission strategy for their Lucentis® (ranibizumab) biosimilar candidate (FYB2010) in the US. In addition, Alteogen announced the completion of its phase I clinical trial of Eylea® (aflibercept) biosimilar (ALT-L9). Both of these biological drugs are used to treat conditions leading to the loss of vision.
Formicon’s Lucentis biosimilar
Formycon and its licensing partner Bioeq AG engaged in successful pre-Biologics License Application (BLA) interactions with the US Food and Drug Administration (FDA). This led to the November 2020 announcement that the initial submission strategy for FYB201 was to be adjusted as part of a simplification of the approval procedure.
Now, with the optimization of the commercial supply chain, FYB201’s approval will occur directly at commercial scale. The BLA-submission is expected to be filed during the first half of 2021, with submission to the European Medicines Agency (EMA) and other highly regulated territories such as Canada, Australia, Switzerland and the UK to follow in due course.
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 patents on Lucentis have already expired in the US and is due to expire in Europe in 2022 [1].
Alteogen’s Eylea biosimilar
Alteogen conducted its phase I clinical trial of ALT-L9 at four major hospitals in South Korea. The randomized, double-blinded, active control and parallel trial was carried out in 28 patients with neovascular (wet) age-related macular degeneration. It confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea. Alteogen will now prove similarity of its product with Eylea through a phase III clinical trial.
Like ranibizumab, aflibercept is also a VEGF inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with diabetic macular edema [2].
Eylea is Regeneron’s blockbuster drug with a reported market size of US$4.947 billion in 2020 in the US alone. Alteogen now has a strong position in the market as it has obtained a formulation patent registered in European Union, Japan and the US and a process patent for its method of producing the aflibercept biosimilar [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-aflibercept
3. GaBI Online - Generics and Biosimilars Initiative. Alteogen wins process patent for aflibercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 16]. Available from: www.gabionline.net/Biosimilars/General/Alteogen-wins-process-patent-for-aflibercept-biosimilar
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