FDA approves interchangeable ranibizumab biosimilar for retinal diseases

FDA has approved Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Lucentis (ranibizumab) for the treatment of multiple retinal vascular diseases.

Ranluspec is approved for the same indications as the reference product, including neovascular (wet) age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Ranluspec is the first interchangeable ranibizumab biosimilar available in the United States in both vial and prefilled syringe formulations. It's approved in the same two strengths as Lucentis: 0.3 mg (6 mg/mL) and 0.5 mg (10 mg/mL), each administered as a 0.05 mL intravitreal injection.

Ranibizumab is an anti–vascular endothelial growth factor (VEGF) agent that binds and inhibits VEGF-A, a key driver of pathologic angiogenesis and vascular permeability in retinal disease. Anti-VEGF therapy remains a cornerstone of treatment for retinal disorders that can lead to vision loss and often requires repeated intravitreal injections over time.

The availability of an interchangeable biosimilar may expand access to anti-VEGF therapy and increase treatment options for retina specialists and ophthalmologists. Interchangeability may also facilitate adoption within health systems and payer formularies where biosimilar substitution is permitted.

Source: Lupin Pharmaceuticals, Inc. 2026 June 4. Lupin Receives Approval from U.S. FDA for Ranluspec (ranibizumab) Injection