On 17 September 2025, Alvotech filed a petition for post grant review of Regeneron’s patent US12168036 entitled “Methods for Treating Angiogenic Eye Disorders with High Doses of VEGF Receptor Fusion Proteins”. The patent was granted on 17 December 2024 and relates to methods for treating an angiogenic eye disorder by intravitreal administration of about 100 microlitres or less of at least about 8mg of a VEGF receptor fusion protein in a formulation with a particular viscosity.
Alvotech’s petition argues that the claims of the patent are invalid for lack of novelty, obviousness, and lack of written description.
Regeneron’s Eylea HD® (aflibercept, 8mg) is approved for nAMD, DME and diabetic retinopathy in the US (August 2023). Regeneron has filed regulatory submissions with the FDA for Eylea HD® in relation to the treatment of macular oedema following retinal vein occlusion (RVO) and an extension of the dosing schedule to include every 4-week dosing across approved indications and an Eylea HD® pre-filled syringe. The FDA’s target action date is Q4/2025.
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.