Yesafili received FDA approval with an interchangeable designation for its vial format in May 2024
| Photo Credit:
Biocon Ltd shares rose 1.22 per cent to ₹401.90 on the NSE on Thursday, July 9, 2026, as the Bengaluru-based biopharmaceutical company announced the publication of two pivotal clinical studies supporting the effectiveness of Yesafili (aflibercept-jbvf), its biosimilar to Eylea (aflibercept), in treating diabetic macular edema (DME).The first study, published in the British Journal of Ophthalmology on June 29, 2026, reported results from a 20-week open-label extension of the Phase III INSIGHT trial. It found comparable safety, efficacy, and immunogenicity outcomes between patients who continued on MYL-1701P and those who switched from the reference drug, with visual and anatomic results maintained across both groups.The second study, published May 18, 2026 in Expert Opinion on Biological Therapy, presented subgroup analyses from the same Phase III INSIGHT trial. Across patient subgroups defined by age, gender, race, glycated hemoglobin levels, and other baseline characteristics, MYL-1701P showed clinically comparable improvements in visual acuity and retinal thickness to the reference product.Yesafili received FDA approval with an interchangeable designation for its vial format in May 2024. The company said these publications strengthen the clinical evidence base ahead of a planned US launch.CEO Shreehas Tambe called the publications an important milestone for the company’s aflibercept biosimilar programme, while Chief Medical Officer Dr. Elena Wolff-Holz said the data reinforced consistency of outcomes following a switch from the reference drug.Biocon’s stock, trading in the NIFTY LARGEMIDCAP 250 index, touched an intraday high of ₹409.60 during the session. The stock has gained 7.51 per cent over the past year, but has underperformed the NIFTY Pharma index, which returned 15.81 per cent over the same period. Total market capitalisation stood at approximately ₹65,128 crore as of Thursday morning.Published on July 9, 2026







