Lupin Receives U.S. FDA Approval for Ranluspec™ (ranibizumab) Injection: Interchangeable Biosimilar for Eye Diseases Now Cleared in the U.S.

Lupin Limited has received approval from the U.S. FDA for Ranluspec™ (ranibizumab-hkdz), an interchangeable biosimilar referencing Lucentis® (Genentech).

Approval granted on June 4, 2026.
Ranluspec is the only interchangeable biosimilar ranibizumab currently approved in the United States, and is available in both vials and pre‑filled syringes (PFS).
Approved strengths are 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL), matching those of Lucentis.

- The product is indicated for treatment of:

Neovascular (wet) age‑related macular degeneration (AMD)
Macular edema following retinal vein occlusion (RVO)
Diabetic macular edema (DME)
Diabetic retinopathy (DR)
Myopic choroidal neovascularization (mCNV)
- Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF‑A) to reduce abnormal blood vessel growth and leakage in the retina.
- Lupin highlighted this approval as a strategic milestone that expands its complex biologics and biosimilars portfolio in the United States.
- Ranluspec has also previously received approval from the European Commission (via the EMA pathway) for several retinal‑related indications, reinforcing its international regulatory standing.
  
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