India, July 9 -- Biocon Ltd. announced the publication of two peer-reviewed clinical studies validating the safety and efficacy of Yesafili™ (aflibercept-jbvf), its biosimilar to Eylea®, reinforcing the clinical evidence ahead of its planned launch in the US market.
The studies, based on the Phase III INSIGHT clinical program, demonstrated that Yesafili delivered safety, efficacy, and immunogenicity outcomes comparable to the reference aflibercept in the treatment of diabetic macular edema (DME). The findings also showed that patients switching from the reference drug to Yesafili maintained similar clinical outcomes.
The first study, published in the British Journal of Ophthalmology, reported positive results from a 20-week exte...