Biocon Limited, an innovation-led global biopharmaceutical company, announced the publication of two important clinical studies supporting the effectiveness of Yesafili (aflibercept-jbvf).
The clinical data from the phase III INSIGHT programme evaluating MYL-1701P, its aflibercept biosimilar, was published in two peer-reviewed journals, contributing to the clinical evidence base supporting the development of aflibercept MYL-1701P for the treatment of diabetic macular edema (DME). MYL-1701P was approved and the vial format was granted interchangeable designation under the name Yesafili by the US Food and Drug Administration in May 2024.
Shreehas Tambe, CEO & managing director, Biocon, said, “Findings from these peer-reviewed publications represent an important milestone for our aflibercept biosimilar program as we prepare for our upcoming launch in the United States. Together, these studies demonstrate how our science-led approach continues to expand access to biosimilars for patients.”
The first manuscript, 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.
This publication reports results from a 20-week, multicenter, open-label extension study enrolling participants with diabetic macular edema (DME) who completed the 52-week global phase III INSIGHT trial. The study evaluated the safety, efficacy and immunogenicity of MYL-1701P in participants who either continued treatment with MYL-1701P or switched from reference aflibercept to MYL-1701P.
Dr Elena Wolff-Holz, chief medical officer, Biocon, said, “The data from these publications reinforce the clinical evidence generated through the phase III INSIGHT trial, demonstrating consistency of outcomes following a switch from reference aflibercept and comparability across clinically relevant patient subgroups. This adds to the growing body of evidence supporting MYL-1701P as a reliable treatment option for diabetic macular edema.” |