The partnership covers an intravenous (IV) nivolumab biosimilar for the European market.

Under the agreement, Shilpa Biologicals will develop, manufacture and exclusively supply the biosimilar from its biologics facility in Dharwad, Karnataka. Orion will exclusively register, market, distribute and sell the product across Europe.

Shilpa will receive development and regulatory milestone payments from Orion. It will also earn long-term supply revenue under the partnership. The financial terms were not disclosed.

The agreement builds on the companies' existing partnership for Recombinant Human Albumin in Europe.

Nivolumab is one of the world's most widely used cancer immunotherapies. The drug generated sales of about $4.1 billion in Europe in 2025, according to IQVIA/IMS data cited by the company.

Shilpa said the partnership aims to expand patient access to a high-quality biosimilar after the originator product loses exclusivity in Europe.

Shilpa Medicare is a diversified pharmaceutical and biotechnology company engaged in the development and manufacture of complex generics, biologics and active pharmaceutical ingredients (APIs). Through its subsidiary Shilpa Biologicals, the company operates a fully integrated biologics platform spanning development, scale-up and commercial manufacturing at its EU-GMP facility in Dharwad, India. Shilpa is known for its focus on innovation, quality and affordability in the global healthcare space.

On a consolidated basis, Shilpa Medicare's net profit soared 642.87% to Rs 107.79 crore while net sales rose 32.09% to Rs 436.99 crore in Q4 March 2026 over Q4 March 2025.