Shilpa Medicare unit inks Nivolumab biosimilar pact with Orion
Shilpa Medicare Limited's wholly owned subsidiary, Shilpa Biologicals Private Limited, has entered into a co-development and supply agreement with Orion Corporation for an intravenous Nivolumab biosimilar targeting the European market. Orion Corporation will hold exclusive commercialization rights, while Shilpa Biologicals will lead development and supply from its Dharwad facility. The partnership targets a market opportunity of approximately USD4.1 billion, aiming to increase patient access to high-quality biosimilars.

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Shilpa Medicare has expanded its partnership with Orion Corporation to co-develop and supply an intravenous Nivolumab biosimilar for the European market. The agreement leverages the loss of exclusivity of the originator drug to increase patient access to high-quality, EU-GMP-manufactured biosimilars across Europe, targeting a market opportunity of approximately USD4.1 billion.
Strategic Partnership With Orion Corporation
Shilpa Biologicals Private Limited, a wholly owned subsidiary of Shilpa Medicare, has entered into a co-development and supply agreement with Finland-based Orion Corporation. The collaboration focuses on the intravenous Nivolumab biosimilar, one of the world's most widely used cancer immunotherapies. Under the terms, Orion Corporation will hold the exclusive right to register, market, distribute and sell the product across Europe, acting as the Marketing Authorization holder in the territory.
| Parameter | Details |
|---|---|
| Partner Company | Orion Corporation |
| Product | Biosimilar of Nivolumab (Intravenous) |
| Compliance Standard | EU-GMP |
| Target Market | Europe |
| Target Market Size | ~USD4.1 billion |
Development And Supply Scope
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. The agreement combines Shilpa's manufacturing capabilities with Orion's commercial and regulatory expertise. Shilpa is entitled to receive from Orion certain development and regulatory milestone payments, in addition to supply revenue over the life of the partnership.
Market Opportunity In PD-1 Immunotherapy
Nivolumab is a blockbuster oncology drug belonging to the PD-1 immunotherapy class. In 2025, Nivolumab recorded sales of approximately USD4.1 billion in Europe, according to IQVIA/IMS data. This partnership aims to widen patient access to advanced immuno-oncology therapy while easing pressure on healthcare budgets. The deal follows the partners’ earlier collaboration to bring Shilpa’s Recombinant Human Albumin to Europe.
Source: https://lodr-files.dhan.co/lodr-inputs/Company/INE790G01031/fe0d8df640ca4b8c.pdf
Historical Stock Returns for Shilpa Medicare
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -4.41% | -3.24% | +14.64% | +81.24% | -35.77% | +112.18% |
What is the projected timeline for regulatory approval and the commercial launch of the Nivolumab biosimilar in Europe?
How will the revenue-sharing model and milestone payments impact Shilpa Medicare’s financial performance over the next five years?
Will this partnership pave the way for similar co-development agreements for other oncology biosimilars in Shilpa’s pipeline?































