Shilpa Medicare's Subsidiary Partners with Orion Corp for IV Nivolumab Biosimilar in Europe
Shilpa Biologicals, a subsidiary of Shilpa Medicare, has partnered with Finland-based Orion Corporation for the co-development and supply of an IV Nivolumab biosimilar for the European market. Shilpa will manufacture and supply the drug, while Orion will handle registration, marketing, and distribution in Europe. The deal aims to increase patient access to the cancer immunotherapy.
The partnership involves a key product in the oncology market and expands the subsidiary's presence in Europe, indicating a medium-term impact on revenue and market share. The financial terms are confidential, limiting a high impact assessment at this stage.
The agreement is positive as it expands Shilpa Medicare's subsidiary's reach into the European market for a significant cancer immunotherapy, leveraging existing capabilities and forming a strategic partnership.
Shilpa Biologicals Private Limited (SBPL), a wholly owned subsidiary of Shilpa Medicare Limited, has entered into a co-development and supply agreement with Orion Corporation, a pharmaceutical company based in Finland. The agreement focuses on the co-development and supply of an intravenous (IV) Nivolumab biosimilar, a widely used cancer immunotherapy.
Under the terms of the agreement, Shilpa Biologicals will lead the product development and serve as the exclusive long-term commercial manufacturer and supplier for the European market from its facility in Dharwad, India. Orion Corporation will hold the exclusive rights to register, market, distribute, and sell the nivolumab biosimilar across Europe, acting as the Marketing Authorization holder. Shilpa is set to receive certain development and regulatory milestone payments, in addition to supply revenue over the partnership's duration.
This collaboration aims to leverage the upcoming loss of exclusivity for the originator nivolumab to increase patient access to a high-quality, EU-GMP-manufactured biosimilar in Europe. The partnership builds upon a previous collaboration between Shilpa and Orion for Recombinant Human Albumin. Vishnukant Bhutada, Managing Director of Shilpa Medicare, expressed enthusiasm for the agreement, highlighting the trust in Shilpa's capabilities. Satu Ahomäki, EVP Generics and Consumer Health at Orion Pharma, noted that this agreement strengthens their hospital segment operations in Continental Europe and aligns with their strategy to provide affordable quality medicines.
Nivolumab generated approximately USD 4.1 billion in sales in Europe in 2025. Orion Corporation reported net sales of EUR 1,890 million in 2025 and has approximately 4,000 employees worldwide.
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Shilpa Medicare Limited filed this with the NSE as a statutory disclosure, categorised under strategic partnerships. It is a primary document, not a recommendation, and the desk marks it medium impact: worth reading, rarely worth acting on by itself.
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