Biocon Releases New Clinical Data Backing Yesafili Biosimilar for Diabetic Macular Edema
New Delhi: Biocon Limited has announced the publication of two peer-reviewed clinical studies supporting the safety, efficacy and comparability of its aflibercept biosimilar Yesafili (aflibercept-jbvf) for the treatment of diabetic macular edema (DME), strengthening the evidence base ahead of its planned commercial launch in the United States.
The studies are based on data from the Phase III INSIGHT clinical programme evaluating MYL-1701P, the biosimilar version of aflibercept. The U.S. Food and Drug Administration (USFDA) approved Yesafili and granted interchangeability status for its vial presentation in May 2024.
Commenting on the development, Shreehas Tambe, CEO and Managing Director, Biocon, said the peer-reviewed publications mark an important milestone for the company's aflibercept biosimilar programme as it prepares for the U.S. launch.
The first study, titled "Safety and Efficacy of Biosimilar Aflibercept MYL-1701P in Diabetic Macular Oedema: 20-Week Extension Results Following the INSIGHT Pivotal Trial," was published in the British Journal of Ophthalmology on June 29, 2026.
The publication reports findings from a 20-week multicentre, open-label extension study involving patients with diabetic macular edema who completed the 52-week global Phase III INSIGHT trial. The study assessed the safety, efficacy and immunogenicity of MYL-1701P in patients who either continued treatment with the biosimilar or switched from the reference aflibercept product.
According to Biocon, the study demonstrated comparable safety, efficacy and immunogenicity between the two groups, with functional and anatomical outcomes maintained throughout the extension period.
The second study, titled "Comparability of Aflibercept Biosimilar with Reference Aflibercept in Diabetic Macular Edema: Subgroup Analysis of the Pivotal Phase III INSIGHT Randomized Clinical Trial," was published in Expert Opinion on Biological Therapy on May 18, 2026.
The subgroup analysis evaluated MYL-1701P against the reference aflibercept across multiple patient characteristics, including age, gender, visual acuity, retinal thickness, glycated haemoglobin levels and prior anti-VEGF therapy.
The analyses showed clinically comparable improvements in best corrected visual acuity and central subfield thickness across most patient subgroups, supporting the clinical equivalence of the biosimilar to the reference product.
Dr Elena Wolff-Holz, Chief Medical Officer, Biocon, said the published data reinforce the evidence generated through the Phase III INSIGHT programme, demonstrating consistent outcomes following a switch from reference aflibercept and comparable efficacy across clinically relevant patient populations.
Yesafili was approved based on analytical, non-clinical and clinical data demonstrating high similarity to the reference product Eylea. In the Phase III INSIGHT trial, the biosimilar showed no clinically meaningful differences from the reference medicine in pharmacokinetics, safety, efficacy or immunogenicity in patients with diabetic macular edema.
