SteinCares, Shilpa Biologicals Partner to Expand Biosimilar Access Across Latin America

SteinCares has entered into a strategic licensing agreement with Shilpa Biologicals Pvt. Ltd., a subsidiary of Shilpa Medicare Limited, to commercialize a biosimilar across the Latin American region.

Under the agreement, SteinCares will hold exclusive rights to register, commercialize, and distribute the biosimilar, while Shilpa Biologicals will complete development and provide long-term commercial manufacturing from its facility in Dharwad, India. The collaboration marks the first product from this partnership and Shilpa Biologicals’ formal entry into the Latin American market.

The alliance combines Shilpa Biologicals’ expertise in biologics development and large-scale manufacturing with SteinCares’ established commercialization network, regulatory experience, and understanding of local healthcare systems. Together, the companies aim to increase patient access to safe, cost-effective biologic treatments and strengthen SteinCares’ leadership in biosimilars across the region.

“This agreement reinforces our leadership in biosimilars and our role as a strategic partner for global biopharmaceutical companies entering Latin America’s complex markets,” said Mitchell Waserstein, CEO of SteinCares.

Dr. Sridevi Khambhampaty, CEO of Shilpa Biologicals, said the partnership supports the company’s global expansion goals: “Through this licensing agreement, we are entering Latin America to broaden patient access and build long-term collaborations.”

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