New Dataโค Confirm Efficacy, Safety of switching โnAMDโฃ Patientsโข to Eylea Biosimilar
A recentโ 52-week randomized, double-maskedโข clinical study published in Ophthalmology retina demonstrates that patientsโค with neovascular age-relatedโ macular degeneration โ(nAMD) can transition from the reference product Eylea (aflibercept) to its โฃbiosimilar, โPavblu (aflibercept-ayyh), without compromising treatmentโ efficacy, safety, or immunogenicity. The findings, released in โคJuly โ2025, add to aโ growing body of evidence supporting the use of biosimilars to expand patient access to critical therapies.
the study, involving a large cohort of nAMD patients, assessed outcomes in three groups: those continuing Pavblu, those continuing Eylea, and those switching from Eylea to Pavblu. Researchers found comparable rates of adverse events (AEs) across all groups, with nAMD, hypertension, and COVID-19 being the most commonly observed. Specifically, AEs wereโค reported in 52.7% of those continuing Pavblu, 52.9% of those continuing Eylea, andโฃ 57.1% of those who transitioned to the biosimilar. nAMD wasโ the most โfrequently reported AE, occurring in โค5.9%, 8.1%,and 7.5% โof patients in theโ respective groups.The study authors concluded that “thisโฆstudy demonstrated that the efficacy, safety, and immunogenicity were not altered by a transition from [the reference] to [its biosimilar].” these results, combined with prior analytical and functional similarity data, contribute to the “totality of evidence” supporting the biosimilarity of Pavblu and Eylea. Pavblu received FDA approval in โAugust 2024, marking the fifth Eylea biosimilar to enter the market.
The research was led by Friedman S,London N,Hamouz J,et al., and is available under DOI: โค10.1016/J.Ot.2025.07.015. Further facts about theโ study (NCT04270747) can be found on ClinicalTrials.gov.