SteinCares and Shilpa Biologicals Collaborate on Biosimilar Access for Latin America

On March 10, 2026, SteinCares, a health care company in Latin America, announced it has entered into a licensing agreement with biopharmaceutical company Shilpa Biologicals Pvt. Ltd.to commercialize biosimilars in Latin America.1 SteinCares will hold the rights to register, commercialize, and distribute the biosimilars across the region, and Shilpa will develop the products and provide long-term commercial manufacturing.

“We are excited to partner with Shilpa Biologicals to bring this biosimilar to Latin America,” said Mitchell Waserstein, CEO of SteinCares, in the press release. “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.”

“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, in the release.1 “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.”

How Is Shilpa Biologicals Expanding Its Reach?

Shilpa Biologicals has traditionally focused on biosimilars development; however, Dr. Khambhampaty spoke with BioPharm International® in November 2025 about the company’s plans to expand into novel therapies and global innovation, which hints at the move into Latin America and strategic partnerships.2

“It's an interesting time with the outsourcing partnerships and evolving biotech and CDMO [contract development and manufacturing organization] space. We have actually started doing several innovative partnerships at Shilpa,” Dr. Khambhampaty stated in the interview.2 “We are looking at equity-based partnerships, also partnerships where we are developing the product as a co-development partner with the startup that has invented or discovered the product, as well as a service-based model wherein we pitch in a part of the service that the company, that's the innovative company, or the discovery company, wants to outsource. So, we've kept a very flexible model.”

Dr. Khambhampaty also spoke about innovation in India and how increased government funding is expanding development of complex modalities, such as antibody drug conjugates (ADCs).

“I think ADCs have made a sort of come back with several ADCs being in the clinical space right now. ADCs [are] a very specialized area, and with not everybody having the capability to make the antibody, make the linker payload, as well as do the conjugation,” Dr. Khambhampaty said. “We are stepping into this niche space by creating our antibody conjugation suit and leveraging expertise from the chemistry side of the organization to synthesize the payloads and linkers. Now I think we can bring it all together to simplify the ADC supply chain.”

References

1. SteinCares. SteinCares and Shilpa Biologicals strike into licensing agreement to expand access to biosimilars across Latin America. Press release. March 10, 2026.
2. Mirasol F. How India’s biotech ecosystem is shifting toward innovation and global partnerships. BioPharmInternational.com. November 3, 2025. https://www.biopharminternational.com/view/how-india-s-biotech-ecosystem-is-shifting-toward-innovation-and-global-partnerships