Biocon Limited announced the publication of pivotal clinical data supporting the effectiveness of Yesafili, a biosimilar to Eylea, ahead of its upcoming launch in the United States. The studies, published in the British Journal of Ophthalmology and Expert Opinion on Biological Therapy, demonstrate comparable safety, efficacy, and immunogenicity outcomes for MYL-1701P, the company's aflibercept biosimilar. The findings strengthen the clinical evidence base for the treatment of diabetic macular edema (DME).

The first manuscript, published on June 29, 2026, details the 20-week extension results following the INSIGHT pivotal trial. The study evaluated participants who continued treatment with MYL-1701P or switched from reference aflibercept. Results showed that both groups maintained visual and anatomic outcomes through the extension period, with similar safety profiles.

The second manuscript, published on May 18, 2026, presents subgroup analyses from the Phase III INSIGHT randomized clinical trial. The analysis showed clinically comparable changes in best corrected visual acuity and central subfield thickness between MYL-1701P and reference aflibercept across diverse patient subgroups.

Key Clinical Findings

The Phase III INSIGHT trial generated a robust dataset across multiple clinical parameters, underscoring MYL-1701P's profile as a reliable biosimilar option. The following table summarizes the key outcomes from the published studies:

Leadership Commentary

Shreehas Tambe, CEO & Managing Director, Biocon, stated that the findings represent an important milestone for the aflibercept biosimilar program. Dr. Elena Wolff-Holz, Chief Medical Officer, Biocon, added that the data reinforce the clinical evidence generated through the Phase III INSIGHT trial, supporting MYL-1701P as a reliable treatment option for diabetic macular edema.

Regulatory Status and Indications

Yesafili was approved and granted interchangeable designation by the U.S. Food and Drug Administration in May 2024. The product is indicated for the treatment of the following conditions:

• Neovascular (Wet) Age-Related Macular Degeneration
• Macular Edema Following Retinal Vein Occlusion
• Diabetic Macular Edema
• Diabetic Retinopathy

According to a report by CNBCTV18, Viatris-owned Mylan is likely to sell a portion of its 5.64% stake in Biocon via block deals, with the transaction expected soon. The development indicates a partial divestment by Mylan from its existing shareholding position in the pharmaceutical firm.

Stake Sale Details

The key details of the reported transaction are as follows:

Mylan, which is owned by Viatris, currently holds a 5.64% stake in Biocon and is reportedly looking to offload a part of this holding through block deals. The report, attributed to CNBCTV18, does not specify the exact quantum of the stake to be divested or the proposed transaction value.