Lupin Limited received approval from the U.S. FDA for Ranluspec, an interchangeable biosimilar referencing Lucentis, on June 4, 2026. This approval marks Ranluspec as the only interchangeable biosimilar ranibizumab approved in the United States available in both vials and pre-filled syringes (PFS). The drug is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

Both the vial and PFS presentations are approved in two strengths: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL). Ranibizumab functions as a recombinant humanized IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A.

Executive Commentary

Vinita Gupta, CEO, Lupin, stated that the approval adds depth to the company's biosimilars portfolio and reflects progress in complex biologics. Nilesh Gupta, Managing Director, Lupin, noted that the approval reinforces scientific rigor and manufacturing capabilities. Dr. Cyrus Karkaria, President Biotechnology, Lupin, highlighted the company's expertise in biologics development and manufacturing.

Product Details

Lupin Limited, in partnership with Natco, has received approval from the U.S. Food and Drug Administration (FDA) for Eribulin Mesylate Injection, a drug used in the treatment of metastatic breast cancer and liposarcoma. This regulatory clearance represents a notable development for both companies as they expand their oncology portfolio in the highly competitive U.S. generics market.

FDA Approval Details

The approved product, Eribulin Mesylate Injection, is indicated for two distinct oncological conditions — metastatic breast cancer and liposarcoma. The joint approval between Lupin and Natco underscores a collaborative approach to bringing complex injectable generics to the U.S. market. Key details of the approval are outlined below:

Market Significance

The U.S. market for Eribulin Mesylate Injection carries an estimated annual sales potential of $43.7 million, highlighting the commercial significance of this approval for both Lupin and Natco. Eribulin Mesylate is an established oncology agent, and its generic availability is expected to provide a cost-effective treatment option for patients in the United States. This approval further strengthens Lupin's presence in the U.S. injectable oncology space, a segment that continues to be a strategic focus for the company.