Lupin Receives USFDA Approval for Interchangeable Biosimilar Ranluspec

Lupin Limited has secured US FDA approval for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar referencing Genentech’s Lucentis, on June 4, 2026. Key Highlights: Unique Market Position: Ranluspec is the only interchangeable biosimilar ranibizumab approved in the US that is available in both vial and pre-filled syringe (PFS) presentations. Dosage & Strengths: Approved in 0.3 mg and 0.5 mg strengths across both the vial and PFS formats. Clinical Indications: Indicated for treating multiple retinal conditions, including neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion. Mechanism of Action: Functions as a recombinant humanized IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A (VEGF-A). Strategic Significance: Commercial Advantage: The "interchangeable" designation allows for pharmacy-level substitution (subject to state laws), driving rapid market penetration. Furthermore, offering both vial and PFS formats gives ophthalmologists maximum flexibility, providing Lupin a distinct competitive edge over rival biosimilars. Portfolio Deepening: The approval significantly expands Lupin’s biosimilars portfolio and solidifies its leadership in the complex biologics segment. Manufacturing Validation: Reinforces the company's scientific rigor and advanced capabilities in complex biologics development and large-scale manufacturing. Outlook: With the US ophthalmology biosimilars market being highly lucrative, Ranluspec's dual-presentation and interchangeable status position Lupin to capture significant market share from the originator (Lucentis) and other competitors. $LUPIN