The global aflibercept biosimilars market size stood at US$ 1.54 billion in 2024, grew to US$ 1.68 billion in 2025, and is forecast to reach US$ 3.7 billion by 2034, expanding at a CAGR of 9.14% from 2025 to 2034.
In July 2025, A SAMSUNG BIOEPIS agreement (DCA) for licensing, development, and commercialization was signed by Samsung Bioepis and Harrow. The deal will give Harrow the sole U.S. commercial rights to the ophthalmology biosimilar portfolio of Samsung, including aflibercept-yszy 0.05 mL injection (OPUVIZ), an FDA-approved biosimilar referencing EYLEA (aflibercept), and HARROW Bioepis-_ranibizumab-nuna 0.05 mL injection (BYOOVIZ), an FDA-approved biosimilar referencing LUCENTIS (ranibizumab).
In May 2025, while two other companies extend their biosimilar partnership to include additional products, the FDA designates two biosimilars as interchangeable, improving access to treatments for multiple sclerosis and inflammatory diseases. Alvotech and Advanz Pharma have extended their European biosimilar collaboration to include new candidates aiming at high-value markets since the FDA granted interchangeable status to two biosimilar biologicals.
Target Identification & Preclinical Studies: Scientists identify therapeutic targets for retinal disorders and test biosimilar candidates in cell cultures and animal models.
Process & Formulation Development: Optimization of cell lines, protein expression, purification, and formulation to match the reference biologic.
Key Players & Organizations: Samsung Bioepis, Sandoz, Amgen, Biocon Biologics, universities, and CROs (Contract Research Organizations).
Phase 1 Trials: Initial human testing for safety, dosage, pharmacokinetics, and immunogenicity.
Phase 2 Trials: Expanded testing to evaluate efficacy, safety, and comparative studies versus reference products.
Phase 3 Trials: Large-scale trials to confirm efficacy, monitor adverse events, and gather comprehensive data for submission.
Regulatory Approvals: Submission to authorities like EMA, FDA, PMDA, or CDSCO for marketing authorization and post-approval compliance.
Education & Counseling: Training patients on intravitreal injections and retinal disorder management.
Adherence Programs: Follow-ups, reminders, and home care services to ensure consistent treatment.
Insurance & Reimbursement Assistance: Guidance for coverage and cost management.
Post-Market Surveillance: Monitoring long-term safety and efficacy in real-world use to inform improvements.
In June 2025, according to Shreehas Tambe, CEO and Managing Director of Biocon Biologics Ltd., Biocon Biologics is proud that Health Canada approved YESAFILI, the first biosimilar to EYLEA in the country. As the tenth biosimilar to be commercialized globally, the company is thrilled to announce that YESAFILI will be introduced in Canada as the first country in July. Biocon Biologics Ltd. is driven by science, with a strength in global commercialization and an ongoing commitment to increasing access to high-quality, reasonably priced biologics, all of which are reflected in this milestone.
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