Alvotech, Advanz Pharma File First Known Biosimilar Application For Eylea 8mg
(RTTNews) - Alvotech (ALVO) and Advanz Pharma have submitted a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg (aflibercept), marking what the companies say is the first known regulatory submission worldwide for a biosimilar version of the high-dose eye disease treatment.
The application was submitted to the European Medicines Agency as a line extension to the existing marketing authorization for Mynzepli (AVT06), Alvotech's biosimilar to Eylea 2 mg.
Under the companies' partnership, Alvotech is responsible for development and manufacturing, while Advanz Pharma holds commercialization rights in Europe.
Eylea is used to treat certain retinal diseases through injections into the eye. According to the approved European prescribing information, the 8 mg formulation allows treatment intervals of up to16 weeks for some patients, compared with the standard eight-week maintenance schedule associated with the 2 mg version. The longer dosing interval has the potential to reduce the number of injections and clinic visits required for eligible patients.
The higher-dose formulation has become an increasingly important part of the Eylea franchise. According to the publicly reported financial results cited by the companies, Eylea 8 mg accounted for approximately 57% of combined global Eylea 2 mg and 8 mg sales by value during the second quarter of 2026, up from about 30% in the same period a year earlier.
AVT29 remains an investigational product and has not received regulatory approval. A biosimilar must undergo a regulatory review before it can be approved for commercial use.
The submission represents the latest step in Alvotech's biosimilar strategy and expands its aflibercept portfolio, following the European approval of Mynzepli, while potentially positioning the company among the first developers targeting the growing market for high-dose aflibercept therapies.
ALVO has traded between $2.94 and $9.05 over the past year. The stock close Tuesday's trading at $5.38, down 2.18%. In pre-market trading the stock is at $5.47, up 1.67%.
