Image Source: HR Katha
Lupin Ltd has announced a major strategic move to expand its global biosimilars footprint, entering into a license and supply agreement with SteinCares for the commercialization of its biosimilar ranibizumab in Latin America. This partnership is set to accelerate patient access to advanced ophthalmic therapies across the region and marks a significant milestone in Lupin’s international growth strategy.
Key Highlights:
Strategic Alliance: Under the agreement, SteinCares will handle all regulatory filings and spearhead commercialization efforts for Lupin’s biosimilar ranibizumab—a therapy used to treat retinal diseases such as wet age-related macular degeneration (AMD)—across Brazil and the broader LATAM region. Lupin will be responsible for manufacturing and supplying the product.
Regulatory Expertise: SteinCares, a leading specialty healthcare company with a strong presence in over 30 Latin American and Caribbean countries, brings deep regulatory and market expertise. Their role includes managing the complex approval process with LATAM health authorities and ensuring a robust go-to-market strategy.
Market Impact: The partnership aims to improve access to affordable, high-quality biologics for patients in Latin America, where demand for advanced ophthalmic treatments is rapidly rising. SteinCares’ extensive distribution network and experience with biosimilars are expected to maximize product reach and adoption.
Biosimilar Credentials: Lupin’s ranibizumab biosimilar has already demonstrated equivalence to Lucentis® in global phase 3 trials and is marketed in India as RaniEyes. The company is actively pursuing regulatory approvals in major global markets, leveraging its proven clinical data and manufacturing capabilities.
Broader Biosimilar Push: The deal adds to a series of recent agreements where SteinCares has partnered with global biopharma firms to bring biosimilars to LATAM, reinforcing its leadership in the region’s specialty pharma landscape.
This collaboration underscores Lupin’s commitment to expanding access to innovative therapies worldwide and positions both companies to capture significant growth in the Latin American ophthalmology market.
Sources: Modern Retina, SteinCares, PharmaBiz, Bio-Thera Solutions
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