In an exchange filing, the company said Shilpa Biologicals will co-develop, manufacture and exclusively supply the biosimilar from its biologics facility in Dharwad, Karnataka. At the same time, Orion will have exclusive rights to register, market, distribute and sell the product across Europe.
The agreement combines Shilpa’s biologics development and manufacturing capabilities with Orion’s commercial and regulatory expertise in Europe.
Nivolumab is one of the world’s most widely used immuno-oncology therapies. According to the company, the drug recorded approximately $4.1 billion in sales in Europe in 2025, citing IQVIA/IMS data.
As per the agreement, Orion will act as the marketing authorisation holder for the product in Europe, while Shilpa Biologicals will serve as the exclusive long-term commercial manufacturer and supplier. Shilpa will also be eligible to receive development and regulatory milestone payments, in addition to supply revenue over the duration of the partnership. The financial terms of the agreement were not disclosed.
The company said the partnership aims to expand patient access to a high-quality biosimilar following the loss of exclusivity of the originator nivolumab in Europe.
“Extending our partnership with Orion into immuno-oncology is a defining moment for Shilpa Biologicals. It reflects the trust our partners place in our quality, our science and our ability to deliver complex biologics at scale,” Vishnukant Bhutada, Managing Director of Shilpa Medicare, said.
Satu Ahomäki, Executive Vice President, Generics and Consumer Health at Orion Pharma, said the agreement strengthens the companies’ existing strategic partnership and supports Orion’s plans to expand its hospital business in Continental Europe while improving access to affordable medicines.
The latest agreement builds on the companies’ earlier collaboration to commercialise Shilpa’s recombinant human albumin in Europe.
Shares of the company jumped 5.6% following the announcement and were trading 4.82% up as of 10.44 am at ₹601.25. The stock has gained over 90% so far this year.
Also read: Delhi EV Policy: Here are the stocks to play the theme, as highlighted by analysts
