Shilpa Biologicals, SteinCares to Expand Biosimilar Access in Latin America

Shilpa Biologicals has signed a licensing agreement with SteinCares to commercialize a biosimilar in the latter’s home region, Latin America.

The strategic pact gives SteinCares exclusive rights to register, commercialize, and distribute the biosimilar. Meanwhile, Shilpa Biologicals, a subsidiary of Shilpa Medicare, will handle product development and commercial manufacturing at its Dharwad, India facility.

Shilpa and SteinCares Backgrounds

SteinCares currently works to expand access to treatments in 30 Latin American countries, with more than 45 years of experience. Shilpa Biologicals operates a hybrid CDMO model that offers development, manufacturing, and license-ready formulations in immunology, oncology, and ophthalmics.

What the biosimilar is was not disclosed, but CEOs Sridevi Khambhampaty, PhD, Shilpa Biologicals, and Mitchell Waserstein, SteinCares, both approve.

“We are entering Latin America and aim to broaden patient access to safe treatments across the region,” Khambhampaty said. “This collaboration will create meaningful value for patients, healthcare systems, and our organizations as we expand our biosimilars footprint.”

Waserstein said the agreement reiterates SteinCares’ position partnering with “global biopharmaceutical companies seeking to enter Latin America’s complex healthcare markets.”

“We are excited to partner with Shilpa Biologicals to bring this biosimilar to Latin America,” Waserstein said. “We are creating scalable healthcare opportunities and expanding access to innovative, cost-effective treatments across the region.”

What This Means for Biosimilar Development

Overall, the companies said, the agreement highlights Shilpa Biologicals’ expertise in biologics development and high-quality commercial manufacturing. It unites this with SteinCares’ integrated platform in the Latin America region.

In June 2025, SteinCares agreed with Bio-Thera Solutions to commercialize a proposed biosimilar of dupilumab across the region.