Mumbai-based pharmaceutical company Lupin Limited has entered into a strategic license and supply agreement with SteinCares, a leading specialty healthcare company in Latin America, to commercialize its biosimilar ranibizumab across the Latin American region, excluding Mexico and Argentina.
Partnership Structure and Responsibilities
Under the terms of the agreement, SteinCares will assume responsibility for all regulatory filings, product registrations, and commercialization activities for ranibizumab throughout the specified Latin American markets. Lupin will retain manufacturing responsibilities for the biosimilar, leveraging its established biotechnology capabilities.
The partnership represents a strategic expansion of Lupin's biosimilar portfolio into key emerging markets, while providing SteinCares with access to a critical ophthalmology treatment that addresses significant unmet medical needs in the region.
Ranibizumab: Mechanism and Clinical Applications
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that specifically binds to and inhibits vascular endothelial growth factor A (VEGF-A). This mechanism of action makes it particularly effective in treating retinal disorders characterized by abnormal blood vessel formation in the eye.
The biosimilar is indicated for treatment of multiple serious retinal conditions, including:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
- Myopic Choroidal Neovascularization (mCNV)
These conditions represent major causes of vision loss and blindness globally, with particularly high prevalence in aging populations and patients with diabetes.
Strategic Significance for Latin American Healthcare
The agreement addresses a critical need for expanded access to advanced ophthalmology treatments in Latin America. SteinCares' established regional presence and regulatory expertise position the company to navigate the complex healthcare landscape across multiple Latin American countries effectively.
"Our partnership with SteinCares underscores our commitment to providing innovative, high-quality healthcare solutions to patients in LATAM," said Dr. Cyrus Karkaria, President of Biotechnology at Lupin. "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."
Sebastián Katz, Chief Strategy Officer at SteinCares, emphasized the partnership's strategic value: "This partnership with Lupin strengthens our portfolio and further reinforces SteinCares' position as a biosimilar powerhouse in Latin America. We have consistently been first to market products from highly regulated markets across several countries in the region."
Market Impact and Cost Considerations
SteinCares has established a track record of bringing biosimilar products to Latin American markets, often achieving first-to-market status across multiple countries in the region. The company's presence has historically translated into significant cost savings for healthcare institutions, driven by decades of experience and deep understanding of Latin America's healthcare landscape.
The introduction of biosimilar ranibizumab is expected to provide more affordable treatment options for patients with retinal disorders, potentially improving treatment accessibility and reducing healthcare system costs across the region. This is particularly significant given the chronic nature of many retinal conditions and the need for ongoing treatment to preserve vision.
The partnership excludes Mexico and Argentina, suggesting these markets may be subject to separate commercial arrangements or regulatory considerations that require different strategic approaches.
