Lupin gains after receiving USFDA nod for Ranluspec

Lupin advanced 1.68% to Rs 2,286.50 after the company announced that the United States Food and Drug Administration (USFDA) has approved its ranibizumab, Ranluspec (ranibizumab-hkdz) injection.

The said injection has been approved as an interchangeable biosimilar referencing to Lucentis, developed by Genentech.

Ranluspec is the only interchangeable biosimilar ranibizumab approved in the United States in both vials and pre-filled syringes (PFS). Both the vial and PFS presentations are approved in both 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).

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A. It is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

Vinita Gupta, CEO, Lupin, said, ?As our second U.S. biosimilar Ranibizumab adds depth to our biosimilars portfolio, reflecting our progress in complex biologics while expanding patient access to proven vision therapies.?

Dr. Cyrus Karkaria, President Biotechnology, Lupin., said, ?The U.S. FDA approval of our biosimilar ranibizumab underscores our scientific expertise in biologics development and manufacturing, and reinforces our commitment to expanding access to advanced, affordable therapies for patients worldwide.?

Lupin is a global pharmaceutical company focused on branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients across multiple therapeutic segments.

Consolidated profit after tax stood at Rs 1,468.70 crore in Q4 FY26, up 87.72% from Rs 782.40 crore in Q4 FY25. Net sales rose 32.9% to Rs 7391.91 crore in Q4 FY26 from Rs 5562.2 crore in Q4 FY25.

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