Lupin has signed a licence and supply agreement with SteinCares to commercialise its biosimilar ranibizumab in Latin American markets, excluding Argentina and Mexico.
SteinCares will manage regulatory filings, registrations and commercialisation efforts for the biosimilar, while Lupin will be responsible for manufacturing.
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The biosimilar is a recombinant humanised immunoglobulin G1 monoclonal antibody fragment that attaches and blocks vascular endothelial growth factor A.
It treats ocular conditions such as neovascular age-related macular degeneration, diabetic retinopathy, myopic choroidal neovascularisation and macular oedema following retinal vein occlusion.
Lupin Biotechnology president Dr Cyrus Karkaria stated: “Our partnership with SteinCares underscores our commitment to providing innovative, high-quality healthcare solutions to patients in Latin America.
“We intend to transform the landscape of retinal care in Latin America, ensuring access to advanced therapies that improve the quality of life of patients.”
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By GlobalDataSteinCares markets and distributes speciality healthcare products in the Latin American region, encompassing biosimilars, pharmaceuticals and complex generics. It operates in more than 30 nations there and the Caribbean.
SteinCares chief strategy officer Sebastián Katz stated: “This partnership with Lupin strengthens our portfolio and further reinforces SteinCares’ position as a biosimilar powerhouse in Latin America.
“Our presence has translated into significant cost savings for healthcare institutions, driven by decades of experience and a deep understanding of Latin America’s healthcare landscape.”
Lupin recently received approval from the US Food and Drug Administration for the abbreviated new drug application for Rivaroxaban tablets USP with 10 mg, 15 mg and 20 mg doses, which are bioequivalent to Janssen Pharmaceuticals’ Xarelto tablets. This product will be produced at Lupin’s Aurangabad facility in India.
In early 2025, Lupin secured approval from the agency for its Sacubitril and Valsartan tablets to treat heart failure.
