Shilpa Medicare and Orion Corporation Collaborate on Nivolumab Biosimilar

Shilpa Medicare's subsidiary, Shilpa Biologicals Private Limited, has entered a strategic agreement with Orion Corporation to co-develop and supply a biosimilar of nivolumab, an innovative immunotherapy drug, for the European market. This collaboration aims to enhance the accessibility of this cancer treatment as patent rights in Europe approach expiration. The original nivolumab had impressive sales of approximately USD 4.1 billion in 2025, underscoring its significant market potential.

Under this agreement, Orion will have exclusive rights to register, market, distribute, and sell the nivolumab biosimilar in Europe. Shilpa Biologicals will handle product development and act as the exclusive manufacturer and supplier within the European market. They will receive milestone payments related to development and regulatory compliance achievements, along with revenue from the supply over the course of the partnership.

Strategic Strengths and Compliance

Shilpa Medicare's Managing Director, Vishnukant Bhutada, expressed confidence in the collaboration, emphasizing the trust their partners place in their expertise in producing complex biologics. Satu Ahomäki of Orion Pharma identified this agreement as a strategic enhancement for their hospital segment operations within Continental Europe, supporting their objective to offer affordable, high-quality medications.

Shilpa Biologicals uses an integrated biologics platform focused on development, scaling, and commercial manufacturing, supported by a compliance facility meeting European Union Good Manufacturing Practices (EU-GMP) in Dharwad, India. Orion Corporation, based in the Nordic region, is a well-established pharmaceutical entity with a diverse product portfolio, heavily focused on oncology and pain therapy.