• organizations:Regeneron
FDA approves first interchangeable aflibercept biosimilars
Products

FDA approves first interchangeable aflibercept biosimilars

Generic equivalents to Eylea demonstrate a comparable quality, safety, and efficacy profile for wet AMD, DME, RVO, and DR.
New data on Eylea HD supports prolonged dosing for wet AMD
Research

New data on Eylea HD supports prolonged dosing for wet AMD

Presented at ARVO, 96-week extending dosing supports reduced need for frequent injections.
Regeneron faces DOJ complaint in alleged Medicare overcharge of Eylea
Legal

Regeneron faces DOJ complaint in alleged Medicare overcharge of Eylea

The U.S. government alleges the company knowingly submitted false average sales prices and, as a result, inflated reimbursements rates.
Regeneron reports extended dosing data on EYLEA HD for wet AMD and DME
Research

Regeneron reports extended dosing data on EYLEA HD for wet AMD and DME

Published in The Lancet, extended dosing intervals at 12 and 16 weeks shows potential for fewer injections
Regeneron files lawsuit against potential Eylea biosimilar
Legal

Regeneron files lawsuit against potential Eylea biosimilar

Company alleges Celltrion’s CT-P42 biosimilar poses a direct threat to its patented technology. 
FDA approves Eylea HD for vision-threatening retinal diseases
Products

FDA approves Eylea HD for vision-threatening retinal diseases

High-dose drug is already approved as a lower dosage for wet AMD, DME, DR, and ROP.
Regeneron releases 2-year PULSAR trial data on aflibercept 8 mg for wet AMD
Pipeline

Regeneron releases 2-year PULSAR trial data on aflibercept 8 mg for wet AMD

Findings show a similar efficacy profile to 2-year data from PHOTON trial for DME.
Regeneron releases 2-year data on aflibercept 8 mg for DME
Pipeline

Regeneron releases 2-year data on aflibercept 8 mg for DME

New findings support 1-year data of interval dosing maintenance; shows similarities to Eylea clinical data.
FDA declines BLA approval for Regeneron's high-dose aflibercept
Pipeline

FDA declines BLA approval for Regeneron's high-dose aflibercept

Agency bases response on an ongoing review of inspection findings at a third-party filler. 
OpRegen phase 1/2a trial data shows promise for GA
Pipeline

OpRegen phase 1/2a trial data shows promise for GA

OpRegen RPE cell therapy is being developed and marketed through a global collaboration with Lineage Cell Therapeutics, Roche, and Regeneron.
FDA grants aflibercept priority review for retinal diseases
Pipeline

FDA grants aflibercept priority review for retinal diseases

Regeneron and Bayer AG are jointly developing aflibercept 8 mg to treat wet AMD, DME, and diabetic retinopathy.
FDA approves Eylea for ROP in preterm infants
Pipeline

FDA approves Eylea for ROP in preterm infants

Latest approval is the first pharmacologic treatment for this patient group.
Court sides with Regeneron in Eylea patent case against Novartis
Legal

Court sides with Regeneron in Eylea patent case against Novartis

Novartis claimed Regeneron’s Eylea (aflibercept) delivery system was in violation of its patent for Lucentis (ranibizumab), a competing AMD drug.