Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

Regeneron’s CRL re 8mg aflibercept identified deficiencies at Catalent Inc.’s facility

Jun 28, 2023

Bloomberg reported that the Complete Response Letter (CRL) issued by the FDA in relation to Regeneron’s BLA for aflibercept 8mg identified deficiencies at Catalent Inc.’s facility in Bloomington, Indiana.  On 27 June 2023, Regeneron announced that that the FDA had issued a CRL in relation to inspection findings at a third-party filler, and that no issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.