Alteogen wins process patent for aflibercept biosimilar

Biosimilars/General | Posted 25/01/2019 post-comment0 Post your comment

South Korean biologicals company Alteogen announced on 4 January 2019 that it had been granted a process patent for its method of producing an aflibercept biosimilar, ALT‑L9, referencing Regeneron’s blockbuster drug Eylea (aflibercept). The patent is a novel method for producing the anti-vascular endothelial growth factor (anti-VEGF) fusion protein.

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Aflibercept is used to treat eye diseases, including neovascular age-related macular degeneration (AMD), macular oedema secondary to retinal vein occlusion, diabetic macular oedema, and diabetic retinopathy. According to Alteogen, the new process increases productivity by optimizing the culture conditions of the cells which produce the proteins essential for biosimilar production, allowing for larger-scale manufacturing. Alteogen indicated in a previous company statement that, in addition to showing similarity to its reference product in US-based preclinical studies, ALT‑L9 was more resilient to high temperatures and had a longer shelf-life due to Alteogen’s formulation technology.

Announcing the patent protection, an Alteogen representative said in a statement that ‘Having this patent in place, we are in the better position to fundamentally block any competitors from developing [an] Eylea biosimilar. We expect that the patent will further strengthen Alteogen’s competitiveness in Eylea biosimilar development, and Alteogen will now become a solid global first mover.’ At least one other biosimilar developer is well placed with its aflibercept biosimilar [1]; Momenta Pharmaceuticals and Mylan’s M710 entered a phase III pivotal trial in August 2018.

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Reference
1.  GaBI Online - Generics and Biosimilars Initiative. Mylan/Momenta announce development strategy for aflibercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 26]. Available from: www.gabionline.net/Biosimilars/General/Mylan-Momenta-announce-development-strategy-for-aflibercept-biosimilar

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