Biocon Publishes Pivotal Clinical Data Supporting Effectiveness of Yesafili Biosimilar for DME

Biocon Publishes Pivotal Clinical Data Supporting Effectiveness of Yesafili Biosimilar for DME​

Biocon Limited, an innovation-led global biopharmaceutical company, has announced the publication of two critical clinical studies validating the effectiveness and safety of Yesafili™ (aflibercept-jbvf), a biosimilar to Eylea®. These publications contribute significantly to the clinical evidence base supporting aflibercept MYL-1701P for treating diabetic macular edema (DME).

Yesafili™, which was granted interchangeable designation by the U.S. Food and Drug Administration in May 2024, is indicated for the treatment of Diabetic Macular Edema (DME), Neovascular Age-Related Macular Degeneration (AMD), and Macular Edema Following Retinal Vein Occlusion (RVO).

The two key findings were published in peer-reviewed journals: one in the British Journal of Ophthalmology and another in Expert Opinion on Biological Therapy.

Safety and Efficacy Extension Results Published​

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 study involved a 20-week, multicenter, open-label extension assessing the safety, efficacy, and immunogenicity of MYL-1701P. The participants included those who continued treatment with MYL-1701P as well as those who transitioned from reference aflibercept to MYL-1701P.

The results demonstrated that both groups showed comparable safety, efficacy, and immunogenicity profiles. Functional and anatomic outcomes, assessed through best corrected visual acuity and central subfield thickness, were maintained throughout the extension period in both treatment cohorts. Safety assessments covered the incidence of ocular and non-ocular treatment-emergent adverse events.

Subgroup Analysis Confirms Clinical Equivalence​

The second publication, titled "Comparability of Aflibercept Biosimilar with Reference Aflibercept in Diabetic Macular Edema: Subgroup Analysis of the Pivotal Phase-III INSIGHT Randomized Clinical Trial," was released on May 18, 2026 by Expert Opinion on Biological Therapy.

This work presented exploratory subgroup analyses from the pivotal Phase III INSIGHT randomized clinical trial comparing MYL-1701P against reference aflibercept in participants with DME. Subgroups were defined using baseline characteristics such as age, gender, visual acuity, central subfield thickness, and anti-drug antibody status.

The analyses indicated clinically comparable changes in best corrected visual acuity and central subfield thickness across most evaluated subgroups at both early and later time points. These findings support the clinical equivalence of the aflibercept biosimilar relative to the reference product within these diverse patient populations.

Shreehas Tambe, CEO & Managing Director of Biocon, commented on the achievement, stating that the peer-reviewed publications mark an important milestone for the company's aflibercept biosimilar program as it prepares for its upcoming launch in the United States. He added that the studies demonstrate how Biocon’s science-led approach is expanding access to biosimilars for patients worldwide.

BIOCON Stock Price Movement​

Shares of Biocon Limited on Wednesday slipped by 2.14% to settle at ₹397.05 after shedding ₹8.70 during trading sessions. The stock traded for a volume of 2,984,173 shares throughout the period.