On 13 October 2025, Regeneron announced that it has been notified by Catalent Indiana, LLC, which was acquired by Novo Nordisk and is the manufacturer filler included in the supplemental BLA for Regeneron’s high dose (8mg) formulation of Eylea® (aflibercept), that Catalent received an “official action indicated” classification from the FDA on 9 October 2025. This classification indicates that the facility is in an “unacceptable state of compliance” after an FDA inspection.
Regeneron’s Eylea HD® (aflibercept, 8mg) is already approved in the US in a vial form for nAMD, DME and diabetic retinopathy (August 2023). However, Regeneron has filed an sBLA in the US for the use of Eylea HD® to treat macular oedema following retinal vein occlusion (RVO) and for an extension of the dosing schedule to include every 4-week dosing across approved indications. Regeneron has also filed a US regulatory submission for Eylea HD® in a pre-filled syringe.
In August 2025, the FDA extended its target action date for these regulatory submissions (to Q4/2025) as a result of FDA observations based on an inspection at Novo Nordisk’s Catalent filling site.
According to Regeneron, while Catalent continues to work with the FDA to resolve the outstanding compliance issues, within the next 3 months, Regeneron is planning to submit an application to the FDA to include an additional manufacturing filler in the Eylea HD® BLA.
Eylea HD® (known as Eylea™ 8mg in Europe) was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.
Eylea® 8mg for intravitreal injection is approved for nAMD and DME including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024). Eylea® 8mg pre-filled syringe (OcuClick) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025). In addition to the US application, Regeneron/Bayer have submitted marketing authorisation applications for Eylea® 8mg for the treatment of patients with macular oedema following RVO in Japan (May 2025) and Europe (April 2025).
Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea® 8mg. Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US. In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 (and AVT06) in Europe.