SteinCares, a specialty healthcare company in Latin America, entered into a strategic licensing agreement with Shilpa Biologicals Pvt. Ltd., a fully integrated biopharmaceutical company and a subsidiary of Shilpa Medicare Limited. Through this collaboration, the two companies aim to commercialize a biosimilar across Latin America and strengthen access to affordable biologic therapies in the region.
Division of Roles in Development and Commercialization
Under the terms of the agreement, SteinCares will hold exclusive rights to register, commercialize, and distribute the biosimilar across Latin America. Meanwhile, Shilpa Biologicals will complete product development and ensure long-term commercial manufacturing at its facility in Dharwad, India.
This structure enables both companies to leverage their core strengths. Shilpa Biologicals will contribute its expertise in biologics development and high-quality manufacturing, while SteinCares will utilize its integrated regional platform, regulatory capabilities, and strong market access across Latin American healthcare systems.
Strengthening Regional Access to Biosimilars
Commenting on the collaboration, Mitchell Waserstein, CEO of SteinCares, said, “We are excited to partner with Shilpa Biologicals to bring this biosimilar to Latin America. 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.”
Building on a Strong Biosimilars Portfolio
As per the press release, the partnership further strengthens SteinCares’ specialty care portfolio and builds on its track record of successfully introducing biosimilars in the region. As a result, the collaboration will empower patients across Latin America with safe, effective, and cost-efficient treatment options.
Expanding Shilpa Biologicals’ Global Reach
Dr. Sridevi Khambhampaty, CEO of Shilpa Biologicals, highlighted the importance of the partnership, stating, “SteinCares is a trusted partner in Latin America with proven expertise in the registration and commercialization of specialty therapies. Through this licensing agreement, we are entering Latin America and aim to broaden patient access to safe treatments across the region.”
She further added, “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 partnership reinforces our commitment to scalable, long-term global licensing collaborations and creates a strong platform for future partnerships across key international markets and our growing biosimilars portfolio.”
