Alvotech and Advanz Pharma announced October 14, 2026, the submission of a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg (aflibercept 114.3 mg/mL), which is marketed as Eylea HD in the United States.¹ Based on publicly available information, the companies say this is the first regulatory submission worldwide for a proposed biosimilar to Eylea 8 mg.¹ The application was submitted to the European Medicines Agency as a line extension to the existing marketing authorization for Mynzepli (AVT06, aflibercept 2 mg), Alvotech’s already-approved biosimilar to Eylea 2 mg.¹
Key facts
- Drug: AVT29 (aflibercept); Alvotech, Advanz Pharma
- Class: VEGF inhibitor fusion protein
- Status: EU line-extension submission filed; not yet approved
- Basis: Extension of Mynzepli's (AVT06; aflibercept 2 mg) EU authorization
- Dosing: Up to 16 weeks (8 mg) vs 8 weeks (2 mg)
- Market share: Eylea 8 mg ~57% of combined Eylea sales, Q2 2026 (vs ~30%, Q2 2025)
- Approvals: Mynzepli approved in EU (August 2025), UK; under review in US, Japan
- Partnership: Alvotech develops/supplies; Advanz Pharma registers/commercializes in Europe
“To our knowledge, this is the first regulatory submission anywhere in the world for a proposed biosimilar to Eylea 8 mg,” said Lisa Graver, JD, CEO of Alvotech, in a company press release.¹ “We recognized early the potential of high-dose aflibercept and invested in developing both the 2 mg and 8 mg formulations. Building on the European approval of Mynzepli, this milestone positions us at the forefront of the next wave of aflibercept biosimilars and reflects our commitment to broadening access to high-quality biologic medicines.”
Why does the high-dose formulation matter for patients?
Eylea is used to treat certain retinal diseases through injections directly into the eye, and according to the approved European product information, the 8 mg formulation allows treatment intervals of up to 16 weeks for certain patients, compared with the standard eight-week maintenance interval for the 2 mg formulation.¹,² Eylea 8 mg accounted for approximately 57% of combined global Eylea 2 mg and 8 mg sales by value in the second quarter of 2026, up from approximately 30% in the same period of 2025, according to Regeneron’s own reported results for the reference product.¹,³
Steffen Wagner, MD, CEO of Advanz Pharma, said in the release that the submission “represents an important milestone in our partnership with Alvotech and our shared commitment to improving access to high-quality, affordable medicines,” adding that the companies are “pleased to be advancing a high-dose formulation that could offer additional treatment options for patients and healthcare professionals across Europe.”¹
How does this submission build on the companies' partnership?
Mynzepli received European Commission approval in August 2025 as a biosimilar to Eylea 2 mg, in both vial and prefilled syringe presentations, for the treatment of several retinal diseases.¹,⁴ Under the companies’ partnership agreement, Alvotech is responsible for development and commercial supply of both AVT06 and AVT29, while Advanz Pharma is responsible for registration and commercialization in Europe, holding exclusive rights except in Germany and France, where the rights are semi-exclusive.¹ Alvotech has also received approval for AVT06 under the brand names Mynzepli and Afiveg in the European Economic Area, as Mynzepli in the United Kingdom, and under the name Aflibercept BS in Japan.¹
