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3 min read | Updated on June 30, 2026, 16:39 IST
SUMMARY
The agreement has been inked for the co-development and supply of an intravenous (IV) nivolumab biosimilar in Europe, referencing one of the world’s most widely used cancer immunotherapies.
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Shilpa Medicare has a total market capitalisation of ₹11,780.87 crore as of June 30, 2026, according to data on the NSE. | Image: Shutterstock.
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The agreement has been inked for the co-development and supply of an intravenous (IV) nivolumab biosimilar, referencing one of the world’s most widely used cancer immunotherapies.
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, according to a regulatory filing.
Meanwhile, 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 will be entitled to receive certain development and regulatory milestone payments, in addition to supply revenue over the life of the partnership from Orion.
It added that the 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, especially as the originator approaches loss of exclusivity in Europe.
“The deal marks another chapter in a fast-growing relationship. It follows the partners’ earlier collaboration to bring Shilpa’s Recombinant Human Albumin to Europe — and pairs Shilpa’s end-to-end biologics development and manufacturing engine with Orion’s deep European commercial reach, regulatory expertise and well-established distribution network,” the filing read.
Commenting on the development, Vishnukant Bhutada, Managing Director of Shilpa Medicare, said that extending the company’s partnership with Orion into immuno-oncology has been a defining moment for Shilpa Biologicals.
“This agreement is a step forward in our efforts to expand and strengthen our operations in hospital segment in Continental Europe, and an indication of the progress of the implementation of our division’s strategy, which aims to create everybody an access to affordable quality medicines,” said Satu Ahomäki, EVP Generics and Consumer Health, Orion Pharma.
In 2025, Nivolumab recorded sales of approximately $4.1 billion in Europe, the company said, citing data from IQVIA/IMS) Europe, adding that this underscores “the scale of the opportunity that high-quality biosimilars can unlock for patients and healthcare systems across the region”.
“Nivolumab helped usher in the era of immuno-oncology, transforming the outlook for patients across cancers such as melanoma and lung cancer,” it stated.
Shilpa Medicare has a total market capitalisation of ₹11,780.87 crore as of June 30, 2026, according to data on the NSE.
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