Shilpa Medicare Limited announced that its wholly owned subsidiary, Shilpa Biologicals Private Limited, signed a co-development and supply agreement with Orion Corporation for a nivolumab biosimilar. This marks the second collaboration between the two companies within the past twelve months and strengthens their strategic partnership in the European biologics market. The agreement aims to improve patient access to nivolumab as the reference product approaches loss of exclusivity across Europe.
Nivolumab: A Major Oncology Opportunity
Nivolumab, marketed as Opdivo, is one of the world’s leading cancer immunotherapies. According to IQVIA/IMS data, the product generated approximately US$4.2 billion in European sales in 2025. As patent exclusivity nears expiry, biosimilar versions are expected to increase patient access to advanced cancer treatments, reduce healthcare costs for European healthcare systems and expand treatment availability across oncology and hospital settings.
Orion Secures Exclusive European Commercial Rights
Under the agreement, Orion Corporation will hold the exclusive rights to develop, register, market, distribute, and sell the nivolumab biosimilar throughout Europe. Orion will also serve as the Marketing Authorisation Holder for the product. Meanwhile, Shilpa Biologicals Private Limited will lead product development, manage technology and regulatory support, act as the exclusive
long-term commercial manufacturing partner for the European market and manufacture the biosimilar at its advanced biologics facility in Dharwad.
Milestone Payments and Long-Term Supply Revenue
In addition to long-term supply revenue, Shilpa Medicare will receive development and regulatory milestone payments from Orion during the course of the partnership. The agreement therefore creates multiple revenue streams for Shilpa while strengthening its position in the global biosimilars value chain.
Strengthening Shilpa’s Global Biologics CDMO Position
For Shilpa Biologicals Private Limited, the partnership represents another important milestone in its transformation into a global biologics CDMO (Contract Development and Manufacturing Organization). The company will take responsibility for activities ranging from early-stage development to long-term commercial manufacturing for one of Europe’s largest upcoming oncology biosimilar opportunities.
Shilpa Highlights Manufacturing Capabilities
“This agreement demonstrates how far Shilpa Biologicals has progressed as a global biologics development and manufacturing partner – it’s another big milestone,” said Vishnukant Bhutada, Managing Director of Shilpa Medicare Limited. “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,” Bhutada added.
Orion Expands Oncology and Hospital Portfolio
“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,” Ahomaki added. As per the press release, the agreement builds on the companies’ existing partnership for the supply of recombinant human albumin in Europe.
