Global pharmaceutical major Lupin Limited has officially announced a strategic licensing and supply agreement with SteinCares, a leading specialty healthcare provider in Latin America. The deal pertains to the commercialization of biosimilar Ranibizumab, a key medication used in retinal therapies, across Latin American markets excluding Mexico and Argentina.

This partnership represents a significant milestone in Lupin’s expansion strategy into emerging markets, while also strengthening SteinCares' already robust biosimilar portfolio. The agreement focuses on addressing the need for affordable and high-quality retinal care solutions throughout Latin America.

Overview of the Partnership

Under the terms of the agreement, SteinCares will take charge of regulatory filings, product registrations, and commercialization of the biosimilar Ranibizumab across various countries in Latin America. Lupin, on the other hand, will retain responsibility for the manufacturing and supply of the product from its biotechnology manufacturing facilities.

This clear division of responsibilities allows each partner to leverage their core strengths — Lupin’s proven manufacturing expertise and SteinCares’ strong market presence and regulatory know-how within Latin America.

About Ranibizumab and Its Medical Importance

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment specifically designed to inhibit vascular endothelial growth factor A (VEGF-A). VEGF-A plays a central role in the formation of abnormal blood vessels in the eye, a leading cause of vision loss in several retinal diseases.

The biosimilar is indicated for the treatment of:

• 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 are chronic and debilitating eye disorders that can lead to permanent vision impairment if left untreated. Ranibizumab works by binding to VEGF-A, thereby preventing abnormal blood vessel formation and leakage, improving vision outcomes for patients.

Statements from Lupin and SteinCares

Dr. Cyrus Karkaria, President of Biotechnology at Lupin, expressed strong optimism about the collaboration:

“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.”

On the other hand, Sebastián Katz, Chief Strategy Officer at SteinCares, highlighted the strategic alignment and long-term benefits of the deal:

“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 with products from highly regulated markets across several countries in the region. 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.”

Strengthening Biosimilar Access in Latin America

Latin America faces uneven access to advanced therapies, particularly in areas like ophthalmology where retinal diseases often remain underdiagnosed or inadequately treated due to the high cost of innovator biologics. This partnership comes at a time when governments, insurers, and healthcare providers are actively seeking biosimilar alternatives to reduce treatment costs and widen patient access.

Through this deal:

• Lupin brings global manufacturing quality aligned with international regulatory standards.

• SteinCares enables seamless navigation of local regulatory environments and ensures market penetration.

• Patients gain access to more affordable biosimilar therapies, improving overall healthcare outcomes.

Why This Deal Matters to Stakeholders

• For Lupin, the deal marks an important milestone in expanding its global biosimilar footprint, particularly in emerging markets.

• For SteinCares, the agreement adds another high-impact therapy to its portfolio, allowing it to capture more market share in LATAM’s ophthalmic treatment segment.

• For patients, the most crucial stakeholders, the partnership will reduce the cost of treatment and increase availability of world-class therapies like Ranibizumab.

Looking Ahead

This licensing and supply agreement also reflects a larger trend in the pharmaceutical industry, where collaborations between global manufacturers and regional distributors are becoming the preferred route to speed up drug access in underserved markets. With biosimilars gaining broader acceptance, the future looks promising for both commercial players and public healthcare systems in Latin America.

Conclusion

The Lupin–SteinCares agreement for Ranibizumab marks a strategic collaboration that balances innovation, affordability, and access in the healthcare landscape of Latin America. As both companies combine their strengths, the ultimate beneficiaries will be patients suffering from vision-threatening retinal diseases who now stand to gain access to effective and affordable therapies.

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