On 12 June 2026, Amgen provided an update in relation to its phase 3 clinical trial for ABP 938 8 mg, biosimilar to Regeneron/Bayer’s Eylea HD® (aflibercept, 8 mg).
The clinical trial was commenced in May 2026 and aims to demonstrate similarity in efficacy between ABP 938 8 mg and US-sourced Eylea HD® by evaluating the change in best corrected visual acuity in patients with nAMD. The trial is being conducted across 18 locations in the US and has an estimated completion date of January 2028.
Eylea HD® (‘high dose’), known as Eylea® 8 mg outside the US, was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both 2 mg and 8 mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.
8 mg Eylea® has been approved to date in more than 60 markets for the treatment of nAMD and diabetic macular oedema (DME), including the US (August 2023). It is also approved for the treatment of patients with macular oedema following retinal vein occlusion (RVO) including in the US (November 2025), Europe (January 2026), the UK (February 2026), Korea (February 2026) and Japan (March 2026).
Alvotech is developing a high dose aflibercept biosimilar, AVT29. In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe. Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2 mg) in the US. Alvotech indicated in March 2026 that it expects to file the first regulatory submission for AVT29 sometime in 2026. In April 2026, Alvotech commenced a phase 3 clinical trial to evaluate the efficacy and safety of AVT29 compared with Eylea HD® in patients with DME, with an estimated completion date of January 2028.