Shilpa Medicare Limited's wholly owned subsidiary Shilpa Biologicals Private Limited has entered into a co-development and supply agreement with Orion Corporation to develop and manufacture a nivolumab biosimilar for the European market, marking the second collaboration between the two companies within a year.

The partnership comes as Bristol Myers Squibb's Opdivo (nivolumab), one of the world's leading cancer immunotherapies, approaches loss of market exclusivity. The reference product generated approximately US$4.2 billion in European sales in 2025, according to IQVIA/IMS.

Under the agreement, Orion will hold exclusive rights to develop, register, market, distribute and commercialise the nivolumab biosimilar across Europe and will serve as the Marketing Authorisation Holder. Shilpa Biologicals will lead product development and act as the exclusive long-term commercial manufacturing partner, producing the biosimilar at its biologics manufacturing facility in Dharwad, India.

In addition to long-term supply revenues, Shilpa Biologicals will receive development and regulatory milestone payments from Orion.

The agreement strengthens Shilpa Biologicals' position as a global biologics contract development and manufacturing organisation (CDMO), expanding its role from product development to commercial-scale manufacturing for one of Europe's largest upcoming oncology biosimilar opportunities.

"This agreement demonstrates how far Shilpa Biologicals has progressed as a global biologics development and manufacturing partner—it's another big milestone," said Vishnukant Bhutada, Managing Director, Shilpa Medicare.

"Orion has seen first-hand our capabilities, and the decision to expand the relationship into one of the world's largest oncology biosimilar opportunities reflects the confidence they have in our team, our manufacturing platform and our ability to deliver at commercial scale," he added.

The latest collaboration builds on the companies' existing partnership for the supply of recombinant human albumin in Europe and further broadens their strategic relationship by combining Shilpa's biologics development and manufacturing expertise with Orion's commercial infrastructure and regulatory capabilities across European markets.

"We are delighted to deepen our strategic partnership with Shilpa," said Satu Ahomaki, Executive Vice President, Generics and Consumer Health, Orion Corporation. "A nivolumab biosimilar is a strong addition to our oncology and hospital portfolio, and we look forward to making it available to patients and healthcare providers right across Europe."

Nivolumab, marketed as Opdivo, is an immune checkpoint inhibitor used to treat multiple cancers, including melanoma, lung cancer, kidney cancer and head and neck cancers. As patents expire, biosimilar versions are expected to expand patient access to immunotherapy while reducing treatment costs for healthcare systems across Europe.