Asia Business Outlook Team | Friday, 05 June 2026
Mumbai-based pharmaceutical company Lupin Limited has received U.S. FDA approval for Ranluspec biosimilar, a biosimilar to Lucentis used in the treatment of serious eye conditions. The approval marks an important step in Lupin’s expansion in the biologics market and strengthens its presence in ophthalmology.
Ranluspec is now approved in the U.S. as an interchangeable Lucentis biosimilar, making it a more accessible treatment option for patients suffering from vision-threatening retinal diseases. The approval is significant because Ranluspec is currently the only interchangeable ranibizumab injection available in both vial and pre-filled syringe formats in the United States.
Ranibizumab is commonly used in eye disease treatment for several retinal disorders that can lead to vision loss if left untreated. Lupin’s Ranluspec has been approved for conditions such as age-related macular degeneration (AMD), diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.
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These conditions are becoming increasingly common, particularly among older adults and people living with diabetes. As demand for retinal disease treatment grows, affordable treatment alternatives are becoming more important for healthcare providers and patients alike.
One of the key highlights of the FDA approval is Ranluspec’s interchangeable status. In the U.S., this designation means pharmacists can substitute the biosimilar for the original reference drug, depending on state regulations, without requiring additional approval from the prescribing doctor. This could help improve patient access to treatment and reduce costs associated with long-term eye care.
For Lupin, this approval also reflects its growing focus on specialty medicines and biologics. While the company has built a strong presence in generic medicines over the years, it is now increasingly investing in advanced therapies that offer higher value and long-term growth opportunities.
The U.S. approval follows Lupin’s earlier success in Europe, where Ranluspec received approval from the European Commission in February 2026. The company has already partnered with Sandoz to commercialize the product in several European markets, helping expand its reach internationally.
The global demand for ophthalmology biosimilars continues to rise, driven by an ageing population and increasing cases of diabetes-related eye complications. Industry experts believe biosimilars will play an important role in making advanced treatments more affordable, especially as healthcare systems face growing cost pressures.
Lucentis, the original branded drug referenced by Ranluspec, has been widely used for years in retinal care. However, biosimilars like Ranluspec are expected to provide similar treatment outcomes at a potentially lower cost, improving access for patients who require regular injections to preserve their vision.
For Lupin, the Lupin FDA approval is more than just a regulatory milestone. It reflects the company’s larger ambition to move beyond traditional generics and establish itself as a stronger player in biologics and specialty healthcare. As competition in the pharmaceutical sector continues to evolve, the company appears focused on building a more diversified and innovation-driven portfolio.
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