Lupin Licenses Biosimilar Ranibizumab for Latin American Markets

Key Takeaways:

• Lupin partners with SteinCares to commercialise biosimilar ranibizumab in Latin America (excluding Mexico and Argentina).
• SteinCares to manage regulatory and marketing duties; Lupin to handle manufacturing.
• Ranibizumab targets multiple retinal disorders, expanding access to affordable eye care solutions.

Lupin pharmaceutical announced that it has entered into a license and supply agreement with SteinCares for the commercialization of biosimilar ranibizumab throughout all of Latin America (excluding Mexico and Argentina). Under the agreement, SteinCares is responsible for regulatory approvals and applications for the product as well as selling the product in all of the respective Latin American markets. Mumbai-based Lupin will manufacture ranibizumab.

Ranibizumab is a recombinant humanized monoclonal antibody fragment (IgG1) that selectively binds and inhibits vascular endothelial growth factor A (VEGF-A). Inhibition of VEGF-A prevents abnormal blood vessel growth and leakage in the eye, a common factor for various diseases related to eyesight.

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The biosimilar has approval for several serious ocular conditions, such as Neovascular (Wet) Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV).

"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," Lupin President Biotechnology Cyrus Karkaria said.