Alteogen Secures Process Patent for Its Aflibercept Biosimilar

Republic of Korea-based biosimilar developer Alteogen has reported that it has been granted a process patent for its method of producing an aflibercept biosimilar, ALT-L9, referencing Regeneron’s innovator drug Eylea.

The patent describes a new, optimized process for producing the anti—vascular endothelial growth factor (anti-VEGF) fusion protein. According to Alteogen, the culture conditions of the cells that produce the proteins necessary for the biosimilar are improved through its new method, allowing for large-scale manufacturing.

In a statement announcing the new patent protection, an Alteogen representative said 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."

In a previous company statement, Alteogen indicated that its ALT-L9 not only showed similarity to its reference product in US-based preclinical studies but also demonstrated greater resilience to high temperatures and had a longer shelf life than the originator drug due to Alteogen’s proprietary technology.

Aflibercept is used for the treatment of eye diseases including neovascular age-related macular degeneration (AMD), diabetic macular edema, macular edema following retinal vein occlusion, and diabetic retinopathy. The brand-name product is an attractive target for biosimilar development, as it has an advantage over competitor anti-VEGF therapy ranibizumab (Lucentis); in some regulatory territories, including the European Union, aflibercept is approved for a so-called “treat-and-extend” dosing approach that reduces the number of injections and clinic visits from 12 to 4 or fewer in the second year of treatment for neovascular AMD. The lower number of intravitreal injections reduces costs and also improves patients’ treatment experience.

The reference aflibercept reached blockbuster status in the third quarter of 2018; Regeneron’s earnings results showed that a steady increase in US sales allowed the drug to bring in $1.02 billion in the United States and $1.68 billion worldwide.

At least 1 other biosimilar developer is well positioned with its biosimilar aflibercept; Momenta and Mylan, which are developing M710, entered a phase 3 pivotal trial of the biosimilar in August 2018.