Alteogen to seek US approval for clinical trials of Eylea biosimilar - (The Korea Herald via NewsPoints Desk)

  • 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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