New immuno-oncology deal marks the second major announcement as Shilpa and Orion deepen strategic partnership
Shilpa Medicare Limited (BSE: 530549 | NSE: SHILPAMED) today announced that its wholly owned subsidiary, Shilpa Biologicals Private Limited (“Shilpa Biologicals”), has entered into a co-development and supply agreement with Orion Corporation for a nivolumab biosimilar. The agreement is the second collaboration between the two companies in the past 12 months and supports broader patient access across Europe as the reference product approaches loss of exclusivity.
Nivolumab [Opdivo] is one of the world’s most successful cancer immunotherapies and generated approximately US$4.2 billion in European sales during 2025 (Source: IQVIA / IMS). As the reference product approaches loss of exclusivity, biosimilars are expected to improve patient access while reducing treatment costs for healthcare systems.
Under the terms of the agreement, Orion will hold the exclusive right to develop, register, market, distribute and sell the nivolumab biosimilar across Europe, and will act as the Marketing Authorisation Holder. Shilpa Biologicals will lead product development and serve as the exclusive long-term commercial manufacturing partner for the European market from its advanced biologics facility in Dharwad, India. In addition to supply revenue over the life of the partnership, Shilpa is also entitled to receive from Orion development and regulatory milestone payments.
For Shilpa Biologicals, the partnership represents another step in its evolution as a global biologics CDMO, with responsibility spanning development through long-term commercial manufacturing for one of Europe’s largest upcoming oncology biosimilar opportunities.
“This agreement demonstrates how far Shilpa Biologicals has progressed as a global biologics development and manufacturing partner – it’s another big milestone,” added Vishnukant Bhutada, Managing Director, Shilpa Medicare. “Orion has seen first-hand our capabilities, and the decision to expand the relationship into one of the world’s largest oncology biosimilar opportunities reflects the confidence they have in our team, our manufacturing platform and our ability to deliver at commercial scale.”
The agreement builds on the companies’ existing collaboration to supply recombinant human albumin in Europe and further expands their strategic partnership. It combines Shilpa’s biologics development and manufacturing capabilities with Orion’s established commercial infrastructure and regulatory expertise across Europe.
“We are delighted to deepen our strategic partnership with Shilpa,” said Satu Ahomaki, EVP Generics and Consumer Health, Orion Corporation. “A nivolumab biosimilar is a strong addition to our oncology and hospital portfolio, and we look forward to making it available to patients and healthcare providers right across Europe.”
