Alvotech and Advanz Pharma submit first global EMA application for an Eylea 8 mg biosimilar
Alvotech and its partner Advanz Pharma filed a European Medicines Agency dossier for AVT29, a proposed biosimilar to the high‑dose 8 mg formulation of Eylea (aflibercept). The filing, made on 14 October 2026, is described as the first regulatory submission worldwide for a biosimilar to this dosage. The application is presented as a line extension to Alvotech’s existing 2 mg biosimilar, Mynzepli (AVT06).
Why it matters
The companies say the submission positions Alvotech among the early developers targeting the growing market for high‑dose aflibercept, which could allow longer injection intervals for patients. If approved, AVT29 would add a lower‑cost option to a segment that represented about 57 % of global Eylea sales by value in Q2 2026, according to the firms’ statements.
Key facts
- 1The EMA application for AVT29 was submitted on 14 October 2026. stocktitan.net
- 2AVT29 is intended as a biosimilar to Eylea 8 mg (aflibercept 114.3 mg/mL). stocktitan.net
- 3The filing is a line extension to the existing European marketing authorisation for Mynzepli (AVT06), Alvotech’s 2 mg aflibercept biosimilar. stocktitan.net
- 4Alvotech is responsible for development and manufacturing, while Advanz Pharma holds exclusive commercialization rights in Europe except for Germany and France. stocktitan.net
- 5Eylea 8 mg accounted for approximately 57 % of combined global Eylea 2 mg and 8 mg sales by value in Q2 2026, up from about 30 % in the same quarter a year earlier. rttnews.com
Open questions
- Material 4 reports that ALVO shares rose 4.62 % in pre‑market trading, while material 5 notes a 1.67 % pre‑market increase; the exact percentage change is inconsistent.
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.