Biocon Biologics Receives European Commission Approval for YESAFILI Biosimilar Aflibercept
Biocon Biologics, a leading biopharmaceutical company, has recently received approval from the European Commission (EC) for its biosimilar drug, YESAFILI®. YESAFILI® is a biosimilar of Aflibercept and is intended for the treatment of various eye conditions, including neovascular age-related macular degeneration (AMD), macular edema secondary to retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (CNV).
European Commission Approval
The EC’s decision to grant marketing authorization for YESAFILI® follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in July. This centralized marketing authorization is valid in all European Union (EU) member states, as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein, and Norway.
Comparability to Reference Product
According to data, YESAFILI® is highly similar to the reference product Eylea® in terms of quality, safety, and efficacy. The EC approval indicates that YESAFILI® has met the necessary regulatory requirements and can be considered a reliable alternative to the reference product.
Impact on Patients
This approval allows Biocon Biologics to expand its biosimilar offerings and provide a meaningful difference to patients in the EU who are affected bythese eye conditions. By offering a cost-effective alternative, Biocon Biologics aims to improve access to treatment and contribute to the overall well-being of patients.
Aflibercept, the reference product for YESAFILI®, had EU brand sales of approximately $1.8 billion for the 12 months ending December 31, 2022, according to IQVIA. With the approval of YESAFILI®, Biocon Biologics has the opportunity to capture a significant share of this market and generate substantial revenue.
With the approval of YESAFILI® in the EU, Biocon Biologics plans to strengthen its presence in the global biosimilars market. The company aims to leverage its expertise in oncology and diabetes products to introduce more biosimilars and address unmet medical needs worldwide.
The European Commission’s approval of YESAFILI® is a significant milestone for Biocon Biologics. This biosimilar drug offers a more affordable treatment option for patients with neovascular AMD, macular edema, and other eye conditions. With its comparable quality, safety, and efficacy to the reference product, YESAFILI® has the potential to make a positive impact on patient care in the EU and beyond.