Lupin and SteinCares Forge Strategic License and Supply Agreement to Commercialize Ranibizumab Biosimilar Across Latin America
Global pharmaceutical leader Lupin Limited (Lupin) has officially announced the signing of a significant license and supply agreement with SteinCares, a prominent specialty healthcare company headquartered in Latin America. This landmark collaboration aims to commercialize Lupin’s biosimilar version of Ranibizumab across the Latin American region, specifically excluding Mexico and Argentina. This agreement marks a crucial milestone in both companies’ ongoing efforts to enhance access to cutting-edge retinal therapies throughout Latin America, a region with a rapidly growing patient population affected by retinal diseases.
Overview of the Agreement
The newly formed partnership designates SteinCares as the exclusive partner responsible for all regulatory filings, registrations, and commercialization activities related to Lupin’s biosimilar Ranibizumab across Latin American countries, excluding Mexico and Argentina. Lupin, a global pharmaceutical powerhouse with expertise in biosimilars and biotechnology, will oversee the manufacturing and supply of the Ranibizumab biosimilar to support SteinCares’ commercialization efforts in the region.
This license and supply agreement allows both companies to leverage their respective strengths: Lupin’s robust manufacturing capabilities and SteinCares’ in-depth knowledge of Latin America’s healthcare infrastructure, regulatory environment, and market dynamics. The collaboration thus promises to accelerate the availability of affordable and high-quality biosimilar treatments for patients suffering from serious retinal conditions.
Understanding Ranibizumab and Its Therapeutic Importance
Ranibizumab is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody fragment specifically designed to bind and inhibit vascular endothelial growth factor A (VEGF-A). VEGF-A is a protein that plays a pivotal role in abnormal blood vessel formation and leakage in the eye, processes that lead to vision loss in various retinal diseases.
The therapeutic indications for Ranibizumab are extensive and critical, covering several serious ophthalmic conditions, including:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD): A leading cause of vision loss among older adults, characterized by the growth of abnormal blood vessels under the retina that leak fluid or blood, causing rapid and severe vision impairment.
- Macular Edema Following Retinal Vein Occlusion (RVO): A condition where blockage of the retinal veins leads to swelling and fluid accumulation in the macula, resulting in vision loss.
- Diabetic Macular Edema (DME): A common complication of diabetic retinopathy, where fluid leaks into the macula due to damaged blood vessels, causing vision impairment in diabetic patients.
- Diabetic Retinopathy (DR): A diabetes-related condition that damages retinal blood vessels and can lead to blindness if untreated.
- Myopic Choroidal Neovascularization (mCNV): Abnormal blood vessel growth in the retina related to high myopia, contributing to progressive vision loss.
The biosimilar version of Ranibizumab developed by Lupin offers an effective, safe, and more affordable treatment alternative to the originator biologic drug. By inhibiting VEGF-A, Ranibizumab reduces pathological angiogenesis and vascular leakage in the retina, thereby helping preserve and sometimes improve vision in affected patients.
Lupin’s Commitment to Latin America and Innovation
Dr. Cyrus Karkaria, President of Biotechnology at Lupin, emphasized the strategic importance of this partnership: “Our partnership with SteinCares underscores our commitment to providing innovative, high-quality healthcare solutions to patients in Latin America. 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 has long been recognized for its commitment to biotechnology and biosimilars, with a vision to address unmet medical needs globally through cost-effective therapies. Their Ranibizumab biosimilar is a testament to their R&D capabilities and dedication to bringing innovative treatments to markets that face significant healthcare access challenges.
This agreement not only extends Lupin’s reach into the Latin American ophthalmology market but also highlights the company’s focus on retinal diseases, which represent a significant burden in the region due to increasing prevalence of diabetes, aging populations, and limited access to advanced treatments.
SteinCares’ Role and Regional Expertise
Sebastián Katz, Chief Strategy Officer at SteinCares, also shared his perspective on the collaboration: “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. 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.”
SteinCares brings to the table extensive expertise in navigating the complex regulatory frameworks of various Latin American countries. Their deep market insights and established commercial networks enable rapid market access and patient reach, critical factors in the successful launch and uptake of biosimilar medicines.
With decades of experience in introducing biosimilars and specialty healthcare products, SteinCares has demonstrated an ability to deliver cost-effective therapeutic solutions that reduce healthcare expenditure without compromising quality. Their leadership in the region’s biosimilar market positions them as an ideal partner for Lupin’s ambitious goals.
Impact on the Latin American Healthcare Ecosystem
Latin America faces a growing burden of chronic diseases, including diabetes and age-related ocular conditions. Access to innovative therapies like Ranibizumab has historically been limited by high costs and regulatory hurdles. The introduction of a biosimilar Ranibizumab through this partnership is poised to significantly improve patient access by providing a more affordable yet equally effective treatment option.
Healthcare systems in Latin America often operate under budget constraints, making biosimilars an attractive solution to expand treatment access while managing costs. Lupin and SteinCares together aim to address this challenge by making advanced retinal care more accessible across multiple countries.
Moreover, the agreement excludes Mexico and Argentina, which may be due to existing commercial arrangements or regulatory considerations, but the inclusion of other key LATAM countries such as Brazil, Chile, Colombia, Peru, and others represents a substantial patient population that stands to benefit from this collaboration.
Strategic Significance
This agreement is part of a broader trend in the pharmaceutical industry, where established global companies collaborate with regional specialists to bring complex biologic therapies to underserved markets efficiently. Such partnerships combine global manufacturing excellence with localized market knowledge, regulatory expertise, and distribution networks.
For Lupin, this partnership enhances its biosimilar portfolio and footprint in Latin America, a region expected to witness robust growth in biologics and biosimilars driven by demographic trends and rising healthcare demand. For SteinCares, it reinforces their strategic ambition to be the leading biosimilar player in Latin America, expanding their offering of high-quality specialty medicines.
As biosimilars continue to gain acceptance worldwide, collaborations like the one between Lupin and SteinCares exemplify how innovation and cooperation can address global healthcare disparities, offering patients in emerging markets access to lifesaving treatments previously out of reach.
The license and supply agreement between Lupin and SteinCares for Ranibizumab biosimilar commercialization in Latin America represents a critical step toward improving retinal healthcare access in the region. By combining Lupin’s manufacturing strength and SteinCares’ regional expertise, the partnership aims to make advanced therapies available to millions suffering from debilitating eye diseases. This collaboration is set to transform the treatment landscape, enhance patient outcomes, and deliver significant value to healthcare systems across Latin America.
