On 14 October 2026, Alvotech and Advanz Pharma announced they have submitted an application to the European Medicines Agency for AVT29, biosimilar to Regeneron/Bayer’s Eylea® 8 mg (aflibercept), known as Eylea HD™ in the US. This is the first known regulatory submission anywhere in the world for a high-dose aflibercept biosimilar.
The application was submitted as a line extension to the existing marketing authorisation for Alvotech/Advanz’s Mynzepli®/AVT06 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg.
Alvotech had indicated in March 2026 that it expected 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 primary completion date of July 2027.
Alvotech and Advanz entered into an agreement in relation to European commercialisation of AVT29 (and AVT06) in June 2024. Under the agreement, Advanz has exclusive commercialisation rights throughout Europe, except in Germany and France, where it holds semi-exclusive rights. Teva holds commercialisation rights for AVT29 (and AVT06) in the US.
Amgen is also developing an 8 mg aflibercept biosimilar, ABP 938, and commenced a phase 3 clinical trial in May 2026, with an estimated primary completion date of July 2027.