Mumbai, India and Naples, Florida, June 5, 2026
Global pharmaceutical company Lupin Limited has secured a major regulatory milestone with the U.S. Food and Drug Administration (FDA) approval of Ranluspec™ (ranibizumab-hkdz), an interchangeable biosimilar referencing Genentech’s blockbuster ophthalmology therapy Lucentis®. The approval marks a significant advancement in Lupin’s expanding biosimilars portfolio and strengthens its position in the rapidly growing biologics market. Importantly, Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations, offering healthcare providers and patients greater flexibility in treatment administration. The product is approved in both strengths available for Lucentis®, enabling broader access to cost-effective therapies for patients suffering from serious retinal diseases that can lead to vision loss and blindness. The approval further highlights Lupin’s growing expertise in complex biologics development, advanced manufacturing, and global regulatory execution.
FDA Approval Expands Access to Vision-Saving Therapies
Ranluspec™ is indicated for the treatment of multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. These conditions collectively affect millions of patients worldwide and represent some of the leading causes of vision impairment and blindness. Ranibizumab works by binding to and inhibiting vascular endothelial growth factor A (VEGF-A), a protein that contributes to abnormal blood vessel growth and leakage in the retina. By blocking VEGF-A activity, the therapy helps preserve vision and slow disease progression.
The FDA’s designation of Ranluspec as an interchangeable biosimilar is particularly significant because it allows pharmacists, subject to state regulations, to substitute the product for the reference biologic without requiring direct intervention from the prescribing physician. This designation can help accelerate adoption, reduce healthcare costs, and improve patient access to critical ophthalmic treatments.
Strengthening Lupin’s Biologics and Biosimilars Portfolio
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The approval represents Lupin’s second biosimilar approval in the United States, reinforcing the company’s commitment to expanding its presence in high-value biologics and specialty medicines. Company leadership emphasized that the achievement reflects years of investment in scientific innovation, manufacturing excellence, and regulatory capabilities. According to Lupin executives, the addition of Ranluspec deepens the company’s biosimilar portfolio while supporting its broader strategy of making advanced therapies more affordable and accessible to patients globally.
As healthcare systems increasingly seek cost-effective alternatives to branded biologics, interchangeable biosimilars are expected to play a crucial role in expanding treatment availability while reducing financial burdens on patients and payers. The approval also underscores Lupin’s ability to compete in complex therapeutic areas traditionally dominated by multinational biotechnology companies.
Growing Demand for Affordable Ophthalmology Biologics
The ophthalmology biologics market continues to experience strong growth due to aging populations, rising diabetes prevalence, and increasing rates of retinal disease worldwide. Demand for effective anti-VEGF therapies remains high as healthcare providers seek proven treatments capable of preserving vision and improving quality of life. With the launch of Ranluspec, Lupin is well-positioned to capitalize on this expanding market while supporting broader healthcare goals related to affordability and access.
The FDA approval not only validates the company’s biologics development capabilities but also strengthens its long-term ambitions in biosimilars, specialty pharmaceuticals, and advanced therapeutic platforms. As competition intensifies within the global biosimilars sector, Ranluspec’s unique interchangeable status and dual presentation formats provide Lupin with a differentiated offering that could drive adoption across the U.S. ophthalmology market, benefiting both healthcare providers and patients seeking reliable, high-quality alternatives to reference biologics.
Source: Lupin press release
