The firm stated that Ranluspec is the only approved interchangeable biosimilar ranibizumab in the United States available in both vial and pre-filled syringe (PFS) formats.
Both formats have received approval for the two strengths available for Lucentis: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL). Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that inhibits vascular endothelial growth factor A.
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The drug is indicated for treating patients with neovascular (wet) age-related macular degeneration, macular edema due to retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
Vinita Gupta, CEO of Lupin, commented, “As our second US biosimilar, Ranibizumab enhances our biosimilars portfolio, showcasing our advancements in complex biologics while increasing patient access to established vision treatments.”
Nilesh Gupta, Managing Director of Lupin, stated, “The approval of Ranluspec highlights our scientific rigor and manufacturing capabilities, driving our goal to create a robust biosimilars portfolio while widening access to high-quality, affordable therapies.”
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“The US FDA’s approval of our biosimilar ranibizumab emphasizes our scientific proficiency in biologics development and manufacturing, reaffirming our dedication to enhancing access to advanced, affordable treatments for patients globally,” remarked Dr. Cyrus Karkaria, President of Biotechnology at Lupin.
Last month, Lupin announced that it had received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g.
The company stated that this product is bioequivalent to the reference listed drug, Sutab tablets from Azurity Pharmaceuticals, Inc. Lupin also mentioned it is the exclusive first-to-file applicant for this product, qualifying for 180-day generic drug exclusivity. The tablets will be produced at the company’s facility in Nagpur, India.
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Lupin Ltd shares closed at ₹2,251.00, down by ₹10.05, or 0.44%, on the BSE.
