Alteogen indicated that it submit an investigational new drug application for ALT-L9, a biosimilar of Regeneron Pharmaceuticals' eye drug Eylea, to the FDA this year, The Korea Herald reported Wednesday.
The firm recently completed pre-clinical studies of the therapy demonstrating biosimilarity without side effects.
"We plan to present the official analysis report of the preclinical results at an academic conference and expect licensing-out negotiations to be accelerated," Alteogen CEO Park Soon-Jae stated.
The company has also developed self-developed formulation technology designed to allow the drug to withstand high temperatures and prolong its shelf life compared to Eylea.
"We believe that our Eylea biosimilar will create higher market value than Lucentis biosimilar products as more patients opt for Eylea because it is more patient friendly due to a less-frequent dosing schedule," an Alteogen official remarked.
The new comes as Samsung Bioepis is set to start late-stage development of SB11, a biosimilar of Roche's Lucentis.
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