Lupin has received approval from the United States Food and Drug Administration (USFDA) for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar referencing Lucentis of Genentech. According to the latest company announcement, the product has been approved in both vial and pre-filled syringe presentations across two strengths: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL). The approval was announced on June 4, making Lupin the only interchangeable biosimilar ranibizumab approved in the United States in both formats. As per CNBC TV18, the drug 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 neovascularisation.
Ranluspec 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 neovascularisation. The approved product is bioequivalent to Lucentis, the reference-listed drug marketed by Genentech. Meanwhile, Eribulin Mesylate Injection is indicated for the treatment of adults with metastatic breast cancer who have previously undergone at least two chemotherapy regimens for metastatic disease. The injection is also used for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. The reference drug Halaven recorded estimated annual sales of approximately $43.7 million in the United States according to IQVIA MAT data for April 2026.
Vinita Gupta, CEO of Lupin, stated that "As our second US biosimilar Ranibizumab adds depth to our biosimilars portfolio, reflecting our progress in complex biologics while expanding patient access to proven vision therapies." Nilesh Gupta, Managing Director, emphasized that "The approval of Ranluspec reinforces our scientific rigour and manufacturing capabilities, advancing our efforts to build a scalable biosimilars portfolio and expanding access to high-quality, affordable therapies." Dr Cyrus Karkaria, President of biotechnology, noted that "The US 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."
This approval follows Lupin's recent regulatory successes, including approval of its abbreviated new drug application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g last month. The company is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity. The tablets will be manufactured at the company's Nagpur facility in India. Lupin operates 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals.
Shares of Lupin Ltd ended at ₹2,251.00, down by ₹10.05, or 0.44%, on the BSE following the announcement. The market reaction reflects investor response to the regulatory approval news and the company's recent financial performance. The approval represents a significant milestone for Lupin in expanding its oncology and biosimilars portfolio in the US market, with both product approvals demonstrating the company's diversified therapeutic capabilities across different drug delivery formats.
