Shilpa Biologicals partners with Orion

Shilpa Medicare announced that its wholly owned subsidiary, Shilpa Biologicals, has entered into a co development and supply agreement with Orion Corporation for intravenous(IV) nivolumab biosimilar referencing one of the world's most widely used cancer immunotherapies ? bringing two companies together to widen patient access across Europe.

Nivolumab helped usher in the era of immuno-oncology, transforming the outlook for patients across cancers such as melanoma and lung cancer. As the originator approaches loss of exclusivity in Europe, this partnership aims to put a high-quality, EU-GMP-manufactured nivolumab biosimilar within reach of more patients ? and to help health systems stretch every euro of their oncology budgets further.

In 2025, Nivolumab recorded sales of approximately USD4.1 billion (Source: IQVIA/IMS) Europe ? underscoring the scale of the opportunity that high-quality biosimilars can unlock for patients and healthcare systems across the region.

Under the agreement, Orion will hold the exclusive right to register, market, distribute and sell the nivolumab biosimilar across Europe, and will act as the Marketing Authorisation holder in the territory. Shilpa Biologicals will lead product development and serve as the exclusive long-term commercial manufacturer and supplier for the European market from its advanced biologics facility in Dharwad, India. Shilpa is entitled to receive from Orion certain development and regulatory milestone payments, in addition to supply revenue over the life of the partnership.