Regeneron's Eylea HD Rejection by FDA
Regeneron is planning to re-apply to the FDA with a new pre-filled syringe manufacturing filler in January 2026.
The US Food and Drug Administration (FDA) has rejected a prefilled syringe version of Regeneron’s ophthalmology blockbuster Eylea HD (aflibercept), due to manufacturing shortcomings.
A complete response (CR) letter was issued for Eylea HD’s pre-filled syringe supplemental biologics licence application (sBLA), citing unresolved issues at a facility of its manufacturing partner, Novo Nordisk.
The FDA uncovered problems during an inspection of Novo Nordisk’s filling plant in Bloomington, Indiana, which was reported by Regeneron in August 2025.
The sole reason for the rejection was unresolved issues at a facility of its manufacturing partner, Novo Nordisk.
Author's summary: FDA rejects Regeneron's Eylea HD due to manufacturing issues.