Formycon, Klinge Biopharma submit biologics license application for Eylea biosimilar

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Formycon and Klinge Biopharma have submitted a biologics license application for FYB203 to the FDA.
FYB203 is a biosimilar to Eylea.

Formycon and Klinge Biopharma have submitted a biologics license application for FYB203, a biosimilar for Eylea, to the FDA, according to a press release.

Eylea (aflibercept, Regeneron) is used to treat several retinal diseases, including neovascular age-related macular degeneration, and is “currently the top selling drug in this pharmaceutical area,” according to the release from Formycon.

Generic FDA News infographic — Formycon and Klinge Biopharma have submitted a biologics license application for FYB203, a biosimilar for Eylea, to the FDA, according to a press release.

The FDA will decide whether to accept the application and move on to further review within 60 days of the submission.

“With FYB203 we are going to address an important as well as growing market for the treatment of severe retinal diseases and contribute to alternative and cost-effective therapeutic options,” Stefan Glombitza, PhD, CEO of Formycon, said in the press release.

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Formycon, Klinge Biopharma submit biologics license application for Eylea biosimilar

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