Lupin Limited has signed a license and supply agreement with SteinCares, a Latin America-based specialty healthcare company, for the commercialization of its biosimilar ranibizumab. The agreement covers all Latin American markets except Mexico and Argentina.
Under the terms of the agreement, SteinCares will be responsible for regulatory filings, obtaining product registrations, and managing commercialization activities for ranibizumab across the specified LATAM region. Lupin will retain responsibility for manufacturing the biosimilar.
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment. It targets and inhibits vascular endothelial growth factor A (VEGF-A), which plays a key role in the formation of abnormal blood vessels in the eye. The biosimilar is used in the treatment of several retinal disorders, including:
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Neovascular (Wet) Age-Related Macular Degeneration (AMD)
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Macular Edema Following Retinal Vein Occlusion (RVO)
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Diabetic Macular Edema (DME)
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Diabetic Retinopathy (DR)
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Myopic Choroidal Neovascularization (mCNV)
The agreement aims to expand access to ophthalmology treatments in Latin America, leveraging SteinCares’ regional presence and Lupin’s biosimilar capabilities.
Dr Cyrus Karkaria, President Biotechnology, Lupin stated, “Our partnership with SteinCares underscores our commitment to providing innovative, high-quality healthcare solutions to patients in LATAM. Our intent is to transform the landscape of retinal care in Latin America, ensuring access to advanced therapies that improve the quality of life of patients.”