Shilpa Medicare is expanding its push into advanced cancer therapies through a new partnership with Orion Corporation to develop and supply an intravenous (IV) nivolumab biosimilar aimed at improving patient access across Europe.
The agreement, signed through Shilpa Medicare’s wholly owned subsidiary Shilpa Biologicals Private Limited, targets one of the world’s most widely used immuno-oncology medicines.
Nivolumab has transformed treatment approaches for cancers including melanoma and lung cancer, and the upcoming loss of exclusivity for the originator product in Europe is opening the door for biosimilar competition.
The partnership aims to deliver a high-quality, EU-GMP-manufactured nivolumab biosimilar to more patients while helping reduce healthcare costs. Nivolumab generated approximately USD 4.1 billion in sales in Europe in 2025, according to IQVIA/IMS, highlighting the significant market opportunity.
Under the agreement, Orion will hold exclusive rights to register, market, distribute and sell the nivolumab biosimilar across Europe. Shilpa Biologicals will lead development efforts and become the exclusive long-term commercial manufacturer and supplier for the region.
Shilpa will receive development and regulatory milestone payments, along with supply revenue throughout the partnership’s lifecycle.
"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.”
“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 strengthens our operations in hospital segment in Continental Europe, and reflects progress of implementation of our division’s strategy to give everybody an access to affordable quality medicines.”
The collaboration strengthens both companies’ positions in the growing biosimilars market, with a focus on expanding access to complex biologic treatments in Europe’s hospital sector.
