Lupin Ltd announced that the US Food and Drug Administration (FDA) has approved Ranluspec (ranibizumab-hkdz) as an interchangeable biosimilar to ranibizumab (Lucentis; Genentech).

According to the company, Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and prefilled syringe presentations. Both delivery formats are approved in the 2 strengths available for Lucentis: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL).

Three other ranibizumab biosimilars have previously received FDA approval: ranibizumab-nuna (Byooviz; Samsung Bioepis/Biogen) in 2021, ranibizumab-eqrn (Cimerli; Coherus BioSciences) in 2022, and ranibizumab-leyk (Nufymco; Formycon AG/Zydus Lifesciences) in 2025.

Ranibizumab is an anti-VEGF-A monoclonal antibody fragment indicated for the treatment of neovascular age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Ranluspec is Lupin's second biosimilar approved in the United States. The company, headquartered in Mumbai, India, markets pharmaceutical products in more than 100 countries.