Mumbai-based Lupin Limited moved Sunday to begin commercial distribution of Ranluspec (ranibizumab injection) across the United States, capitalising on its unique regulatory status as the only interchangeable biosimilar to Genentech's Lucentis approved by the U.S. Food and Drug Administration. The launch positions Lupin to capture a significant share of the anti-VEGF retinal therapy market, which generates billions of dollars annually in the U.S. alone.

Ranluspec's interchangeable designation is commercially critical: it allows pharmacists in most U.S. states to substitute the biosimilar for Lucentis without requiring a separate prescription from the treating ophthalmologist, a legal and logistical advantage no other ranibizumab competitor currently holds. Lupin's U.S. commercial team has been briefing major ophthalmology practices, hospital systems, and pharmacy benefit managers ahead of Sunday's formal market entry.

The drug is indicated for neovascular age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, and myopic choroidal neovascularisation — conditions affecting millions of Americans. Lupin is expected to price Ranluspec at a discount of approximately 20 to 35 percent below the Lucentis list price, according to analysts familiar with the company's biosimilar pricing strategy.

Industry observers note that while Genentech's Lucentis has faced competition from off-label Avastin use and Regeneron's Eylea, the formal entry of an FDA-designated interchangeable biosimilar represents a structural shift. Managed care organisations and large ophthalmology networks have signalled openness to formulary switches where cost savings can be demonstrated without compromising clinical outcomes.

Lupin's chief executive has described the Ranluspec launch as a cornerstone of the company's U.S. specialty biologics strategy, with further biosimilar filings in the ophthalmology and immunology segments anticipated before the end of 2026. Analysts at several brokerages upgraded Lupin's stock outlook on Friday following confirmation of the FDA approval, citing the interchangeable designation as a durable competitive moat in a crowded biosimilar landscape.