Lupin Strengthens Global Footprint with Biosimilar Ranibizumab Deal in Latin America

In a strategic move aimed at expanding its international presence, Indian pharmaceutical major Lupin has signed a licensing and supply agreement with SteinCares, a leading player in the Latin American pharmaceutical sector. The partnership will enable the commercialization of Lupin’s biosimilar Ranibizumab across key Latin American markets—excluding Mexico and Argentina.

This agreement marks a significant milestone in Lupin’s ambition to bring affordable and high-quality biologics to emerging global markets, with a specific focus on retinal care therapies. Under the terms of the deal, SteinCares will manage all regulatory filings, marketing authorizations, and commercial operations, while Lupin retains full responsibility for manufacturing the biosimilar product.

What is Ranibizumab?

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that specifically targets vascular endothelial growth factor A (VEGF-A). VEGF-A plays a central role in the abnormal blood vessel growth and leakage seen in various retinal diseases.

The biosimilar version of Ranibizumab offers therapeutic benefits for conditions such as:

• 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 chronic vision disorders are a leading cause of visual impairment across aging and diabetic populations globally, and particularly in Latin America, where access to advanced therapies has traditionally been limited due to high costs.

A Win-Win Collaboration

Speaking on the agreement, Dr. Cyrus Karkaria, President of Biotechnology at Lupin, emphasized the company’s commitment to global health equity.

“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,” he stated.

By leveraging SteinCares’ strong commercial presence and regulatory expertise in Latin American markets, Lupin aims to accelerate the entry of its biosimilar into countries where healthcare systems are in need of cost-effective, world-class treatment options.

Why This Matters

Biosimilars are gaining increased attention as cost-effective alternatives to expensive biologic treatments. As governments and healthcare providers look to contain costs without compromising on quality, biosimilars are becoming an essential part of sustainable healthcare systems.

Latin America, with its growing diabetic and aging population, presents a large, underserved market for ophthalmologic biosimilars. The Lupin-SteinCares deal will not only improve therapeutic access but also bolster the Indian pharma company’s standing in global biosimilar markets.

Lupin’s Global Strategy in Biotech

This agreement aligns with Lupin’s broader strategy to build a strong global biosimilar pipeline. The company has been actively investing in biotechnology, and this collaboration adds to its expanding portfolio of international licensing deals. Lupin’s biotech division has shown consistent growth and innovation, particularly in ophthalmology, oncology, and autoimmune segments.

The tie-up also reflects a trend in the pharmaceutical industry where Indian firms are increasingly partnering with regional leaders to ensure faster, regulated entry into foreign markets while maintaining control over manufacturing quality and compliance.

Looking Ahead

As regulatory processes are initiated and commercial plans unfold, both companies are optimistic about the potential impact of this partnership. With Ranibizumab biosimilar expected to be priced competitively, it could significantly lower treatment costs for retinal disorders across the region, benefiting thousands of patients who otherwise might not have access to such care.

For now, Lupin’s foray into Latin America’s biosimilar market is more than just a business expansion—it’s a step toward reshaping retinal healthcare accessibility in developing economies.