Regeneron's Eylea HD Rejected 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.
- The FDA issued a complete response (CR) letter for Eylea HD’s pre-filled syringe supplemental biologics licence application (sBLA).
- The rejection was caused by 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, reported by Regeneron in August 2025.
The gold standard of business intelligence.
Author's summary: FDA rejects Regeneron's Eylea HD due to manufacturing issues.