Alteogen Secures Process Patent for Aflibercept Biosimilar, Claims Competitive Advantage
核心洞察
Alteogen has been granted a process patent for its aflibercept biosimilar ALT-L9, which optimizes cell culture conditions to enable large-scale manufacturing of the anti-VEGF (搜索) fusion protein.
The company claims this patent positions them to block competitors from developing Eylea biosimilars and establishes them as a global first mover in aflibercept biosimilar development.
ALT-L9 demonstrated similarity to the reference product in US preclinical studies while showing greater temperature resilience and longer shelf life than the originator drug.
Republic of Korea-based biosimilar developer Alteogen has secured a process patent for its method of producing an aflibercept biosimilar, ALT-L9, referencing Regeneron's innovator drug Eylea. The patent describes an optimized process for producing the anti-vascular endothelial growth factor (anti-VEGF (搜索)) fusion protein used to treat various eye diseases.
Enhanced Manufacturing Process
According to Alteogen, the new process increases productivity by optimizing the culture conditions of cells that produce the proteins essential for biosimilar production. This optimization allows for larger-scale manufacturing compared to conventional methods. The company's proprietary technology has enabled ALT-L9 to demonstrate not only similarity to its reference product in US-based preclinical studies but also superior stability characteristics.
The biosimilar candidate showed greater resilience to high temperatures and had a longer shelf life than the originator drug due to Alteogen's formulation technology, potentially offering advantages in storage and distribution.
Strategic Market Position
An Alteogen representative emphasized the competitive implications of the patent protection, stating: "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."
However, Alteogen faces competition in the aflibercept biosimilar space. Momenta Pharmaceuticals (搜索) and Mylan's M710 candidate entered a phase III pivotal trial in August 2018, indicating that other developers are also well-positioned in this market.
Clinical Applications and Market Opportunity
Aflibercept is used to treat multiple eye diseases, including neovascular age-related macular degeneration (搜索) (AMD), macular edema (搜索) secondary to retinal vein occlusion (搜索), diabetic macular edema (搜索), and diabetic retinopathy (搜索). The drug represents an attractive target for biosimilar development due to its clinical advantages over competitor anti-VEGF (搜索) therapy ranibizumab (Lucentis).
In some regulatory territories, including the European Union, aflibercept is approved for a "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. This reduced injection frequency not only lowers costs but also improves patients' treatment experience by minimizing the burden of intravitreal injections.
The reference aflibercept achieved blockbuster status in the third quarter of 2018, with Regeneron's earnings results showing steady growth in US sales. The drug generated $1.02 billion in the United States and $1.68 billion worldwide, demonstrating the significant market opportunity for successful biosimilar competitors.