Bengaluru: Biocon Biologics Limited is now a step closer to launching its Aflibercept biosimilar, after gaining approval from the US FDA under the name Yesafili in May 2024. It has published Phase III data from its INSIGHT program evaluating the clinical evidence in two peer-reviewed journals to support the treatment of diabetic macular edema (DME), an ophthalmic disorder.
The market for treating DME is about $5.89 billion, currently being served by the reference drug Eylea in the United States. According to the trials, patients who switched from Aflibercept to Yesafili saw proven functional and anatomic outcomes. The Phase III trials assessed safety by the incidence of ocular and non-ocular treatment adverse events and gauged efficacy outcomes based on corrected visual acuity. The findings were published in the British Journal of Ophthalmology on June 29, 2026 as well as the Expert Opinion on Biological Therapy on May 18, 2026.
“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.” Shreehas Tambe, CEO & Managing Director, Biocon, said in a press release.
“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.” Dr. Elena Wolff-Holz, Chief Medical Officer, Biocon, added.
With 19.8 million Americans living with age-related macular degeneration, there is significant scope for Biocon to tap the market, with this injection offering them a cure for a life-threatening eye disorder, besides other challenges.
Though a timeline for launch isn’t clear yet, the entry of Yesafili could trigger a price competition in the US ophthalmic market, allowing Biocon to capture about 15-20% of the market within 2 years. For investors, this remains a strong bullish signal as this biosimilar could contribute almost 150-200 bps to Biocon’s EBITDA margin in the medium term.
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