Orion and Shilpa Medicare Expand Partnership to Develop and Supply Nivolumab Biosimilar for Europe

Dharwad (Karnataka) [India], July 6: Shilpa Medicare Limited announced that its wholly owned subsidiary, Shilpa Biologicals Private Limited, has entered into a co-development and supply agreement with Orion Corporation for intravenous (IV) nivolumab biosimilar referencing one of the world's most widely used cancer immunotherapies to widen patient access across Europe.

Nivolumab helped usher in the era of immuno-oncology, transforming the outlook for patients with cancers such as melanoma and lung cancer. As the originator approaches loss of exclusivity in Europe, this partnership aims to put a high-quality, EU-GMP-manufactured nivolumab biosimilar within reach of more patients, reducing healthcare burden. In 2025, Nivolumab recorded sales of approximately USD4.1 billion (Source: IQVIA/IMS) Europe -- underscoring the scale of the opportunity.

Under the agreement, Orion will hold the exclusive rights to register, market, distribute and sell the nivolumab biosimilar across Europe. Shilpa Biologicals will lead product development and serve as exclusive long-term commercial manufacturer and supplier for Europe. Shilpa will receive development and regulatory milestone payments, and supply revenue over life of partnership.

"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 Ahomaki, 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."

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