Lupin Secures U.S. FDA Approval for Interchangeable Ranibizumab Biosimilar
Mumbai-based pharmaceutical company Lupin has received approval from the U.S. Food and Drug Administration (FDA) for Ranluspec™ (ranibizumab-hkdz), an interchangeable biosimilar to Genentech’s Lucentis®, marking a significant milestone in the company’s growing biologics portfolio.
The approval makes Ranluspec the only interchangeable ranibizumab biosimilar available in the United States in both vial and pre-filled syringe (PFS) presentations. Both dosage strengths corresponding to the reference product—0.3 mg and 0.5 mg—have received approval.
Ranibizumab is a recombinant humanized monoclonal antibody fragment that targets vascular endothelial growth factor A (VEGF-A), a key driver of abnormal blood vessel growth in the eye. It is indicated for several retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.
The FDA’s designation of Ranluspec as an interchangeable biosimilar is particularly noteworthy. Unlike standard biosimilars, interchangeable biosimilars can be substituted for the reference product at the pharmacy level, subject to state regulations, potentially improving patient access while reducing treatment costs.
“This approval adds depth to our biosimilars portfolio and reflects our progress in complex biologics while expanding patient access to proven vision therapies,” said Vinita Gupta, Chief Executive Officer of Lupin.
Nilesh Gupta, Managing Director of Lupin, said the approval reinforces the company’s scientific and manufacturing capabilities while advancing its strategy to build a scalable biosimilars business.
According to Cyrus Karkaria, the approval underscores Lupin’s expertise in biologics development and manufacturing and strengthens its commitment to improving access to advanced and affordable therapies globally.
The U.S. approval follows the recent approval of Ranluspec by the European Commission earlier this year, further expanding the global footprint of Lupin’s biosimilar program. In Europe, the product received approval in both vial and pre-filled syringe formats following a positive recommendation from the European Medicines Agency. (Lupin)
For Lupin, this represents another step in its transition from a traditional generics manufacturer toward a broader biotechnology and biosimilars player. The company currently markets products in more than 100 countries and has been investing heavily in complex generics and biologics to address growing global demand for affordable advanced therapies.
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