Sandoz Receives FDA Approval for ENZEEVU™, Expanding Ophthalmology Biosimilar Portfolio
Sandoz has secured FDA approval for ENZEEVU™ (aflibercept-abzv), a biosimilar to EYLEA®, to treat retinal conditions like wet age-related macular degeneration (AMD) and diabetic retinopathy. This approval strengthens Sandoz's U.S. biosimilar portfolio, offering a cost-effective alternative for managing retinal diseases.
Key Highlights
FDA Approval: ENZEEVUTM has been approved as a therapeutic equivalent to EYLEA®, providing a reliable and affordable option for retinal disease treatment.
Target Indications: The biosimilar is indicated for various retinal conditions, including wet AMD, diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO).
Market Impact: ENZEEVUTM reinforces Sandoz's commitment to making high-quality biosimilars accessible in the U.S. market, particularly within ophthalmology.
Economic Significance: The biosimilar's introduction is expected to lower treatment costs while maintaining the efficacy and safety standards of the reference product.
Sandoz’s Commitment: This approval aligns with Sandoz’s broader strategy to expand its biosimilar portfolio and improve patient access to affordable medications.
Claire D’Abreu-Hayling, Chief Scientific Officer at Sandoz, emphasized the significance of this approval, stating, “nAMD, or wet AMD, continues to be a leading cause of vision impairment in patients over 50 years in North America. This condition affects millions of people, leading to significant challenges in their daily lives due to the progressive loss of central vision. The US approval of ENZEEVU™ is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease.”
