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# FDA Approves Lupin's Interchangeable Lucentis Biosimilar
- URL: https://www.fdaweb.com/fda-approves-lupins-interchangeable-lucentis-biosimilar/
- Published: 2026-06-05T12:00:00.000Z
- Updated: 2026-09-14T13:40:36.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161267

FDA has approved a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucentis.

Ranluspec references Lucentis, a vascular endothelial growth factor (VEGF) inhibitor widely used in ophthalmology to treat vision-threatening retinal diseases. The biosimilar is approved for the same major indications as the reference product, including neovascular, or wet, age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion and myopic choroidal neovascularization.

According to the company, Ranluspec is the only interchangeable ranibizumab biosimilar approved in the U.S. in both vial and pre-filled syringe presentations. The FDA approved both dosage strengths marketed for Lucentis: 0.3 mg and 0.5 mg.

Ranibizumab works by binding to and inhibiting VEGF-A, a protein involved in the abnormal blood vessel growth and leakage that can lead to vision loss in retinal diseases, according to Lupin.