Shilpa Biologicals, Stein Cares Ink Exclusive Biosimilar Licensing Pact for Latin America

Under the agreement, Stein Cares will hold exclusive rights to register, commercialize, and distribute the biosimilar across the region while Shilpa Biologicals will complete product development and provide long-term commercial manufacturing from its facility in Dharwad, India.

The partnership brings together Shilpa Biologicals’ expertise in biologics development and high quality commercial manufacturing with Stein Cares’ integrated regional platform, combining regulatory capabilities, market access, and deep understanding of Latin American healthcare systems.

"We are excited to partner with Shilpa Biologicals to bring this biosimilar to Latin America," said Mitchell Waserstein, CEO of Stein Cares. "This agreement reinforces our leadership in biosimilars and our role as a strategic partner for global biopharmaceutical companies seeking to enter Latin America’s complex healthcare markets. By combining Shilpa’s proven capabilities in biologics development and manufacturing with our integrated regional platform and deep market expertise, we are creating scalable healthcare opportunities and expanding access to innovative, cost-effective treatments across the region.”

This partnership builds on Stein Cares' track record of successfully introducing biosimilars in the region, and strengthens its specialty care portfolio, empowering patients with safe and cost effective treatments across Latin America.

"SteinCares is a trusted partner in Latin America with proven expertise in the registration and commercialization of specialty therapies," said Dr Sridevi Khambhampaty, CEO of Shilpa Biologicals. "Through this licensing agreement, we are entering Latin America and aim to broaden patient access to safe treatments across the region. We believe this collaboration will create meaningful value for patients, healthcare systems, and our organizations as we expand our biosimilars footprint in Latin America. This collaboration reinforces our commitment to scalable, long-term global licensing partnerships and creates a strong platform for future collaborations across key international markets and our growing biosimilars portfolio.”

SteinCares is a specialty pharmaceutical company dedicated to expanding patient access to innovative and cost-effective treatments across Latin America. With more than 45 years of combined experience and an integrated "one-stop-shop" platform spanning 30 countries across Latin America and the Caribbean, SteinCares combines deep local expertise, regulatory agility, and end-to-end operational capabilities—from licensing and commercialization to market access and patient support. SteinCares has pioneered the introduction of biosimilar therapies in the region and maintains a diversified portfolio across innovative medicines, biosimilars, and complex generics.

Shilpa Biologicals is a fully integrated biopharmaceutical company with a therapeutic focus on immunology, oncology, and ophthalmics. As a "hybrid" CDMO/pharma company, Shilpa offers both development and manufacturing services alongside ready-to-license novel formulations. The company's technology platforms enable patient access to high-quality, cutting-edge biopharmaceuticals in global markets. Shilpa Biologicals currently has a pipeline of biosimilars at various stages of development and provides developmental and manufacturing services to global customers from its facility in Dharwad, Karnataka.