SteinCares and Shilpa Biologicals strike into licensing agreement to expand access to biosimilars across Latin America

New Delhi: SteinCares, a leading specialty healthcare company in Latin America, and Shilpa Biologicals Pvt. Ltd., a fully integrated biopharmaceutical company and subsidiary of Shilpa Medicare Limited, has announced a strategic licensing agreement to commercialize a biosimilar across Latin America.

Under the agreement, SteinCares 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 SteinCares’ 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 SteinCares. “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 SteinCares’ 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.”