Russian biopharma Generium has launched Elizaria, a biosimilar version of Alexion’s Soliris (eculizumab) developed using the SUREtechnology Platform from Selexis.
Approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), Soliris (eculizumab) pulled in $3.6 billion (€3.2 billion) in global sales for Alexion Pharmaceuticals in 2018.
While Alexion is confident its IP will restrict direct competition in the US and Europe potentially up until 2027, the first biosimilar has been approved and launched in Russia in the form of Generium’s Elizaria.
Elizaria is generated using Selexis’ SUREtechnology Platform, which according to Selexis’ CEO Igor Fisch played a major part in bringing the biosimilar to market and reducing the costs of goods.
“As with all biologics, the development of biosimilars is fundamentally a two-step process. First, a high-producing, stable cell line must be established. Second is a scale-up process that supports generation of properly folded and glycosylated products,” he told Bioprocess Insider.
“Our Selexis CHO-M Cell Line containing Selexis Genetic Elements (SGEs) generates high quantities of quality product, stably over time and under high-cell-density conditions in a large bioreactor.”
These “SGEs are unique epigenetic DNA-based elements that control the dynamic organization of chromatin in all mammalian cells,” he continued. “This allows for higher and more stable expression of recombinant proteins. Like small-molecule generics, the value proposition of biosimilars is a reduction in the cost of goods.”
This is the fifth Selexis SUREtechnology Platform-generated biologic approval for Generium, though only the first program that Generium has allowed Selexis to fully disclose.
Outside of Russia, several companies are developing eculizumab biosimilars, including Amgen, Samsung Bioepis.