Shilpa Medicare has announced that its wholly owned subsidiary, Shilpa Biologicals, has signed a co-development and supply agreement with Orion Corporation for an intravenous (IV) nivolumab biosimilar.
The move is aimed at expanding access to one of the world’s most widely used cancer immunotherapies across Europe.
Nivolumab, a cornerstone of modern immuno-oncology, has helped reshape treatment outcomes in cancers such as melanoma and lung cancer. As the originator product moves toward loss of exclusivity in Europe, the partnership is positioned to introduce a high-quality, EU-GMP-manufactured biosimilar, with the stated goal of broadening patient access while easing pressure on oncology budgets.
In 2025, Nivolumab recorded sales of approximately USD4.1 billion 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 exclusive rights to register, market, distribute and sell the biosimilar across Europe and will act as the Marketing Authorisation holder.
Shilpa Biologicals will lead development and remain the exclusive long-term commercial manufacturer and supplier for the European market from its biologics facility in Dharwad, India. Shilpa is also entitled to receive development and regulatory milestone payments, along with ongoing supply revenue over the life of the partnership.
The deal extends an existing collaboration between the two companies, following their earlier partnership to bring Shilpa’s Recombinant Human Albumin to Europe. It combines Shilpa’s integrated biologics development and manufacturing capabilities with Orion’s established European commercial infrastructure, regulatory expertise, and distribution network.
"Extending our partnership with Orion into immuno-oncology is a defining moment for Shilpa Biologicals,” said Vishnukant Bhutada, Managing Director, Shilpa Medicare. “It reflects the trust our partners place in our quality, our science and our ability to deliver complex biologics at scale — and it moves us closer to our mission of making advanced medicines affordable and accessible worldwide.”
“We are pleased to add yet another product to our strategic partnership with Shilpa,” said Satu Ahomäki, EVP Generics and Consumer Health, Orion Pharma.
“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.”
