Shilpa Medicare Subsidiary Partners with Orion Corporation to Co-develop Nivolumab Biosimilar for European Market

Shilpa Medicare Subsidiary Partners with Orion Corporation to Co-develop Nivolumab Biosimilar for European Market​

Shilpa Biologicals Private Limited, a subsidiary of Shilpa Medicare Limited, has partnered with Finland-based Orion Corporation to co-develop and supply an intravenous (IV) nivolumab biosimilar. This collaboration aims to increase patient access to high-quality cancer immunotherapy across Europe as the originator drug approaches loss of exclusivity in the region.

The partnership combines Shilpa’s manufacturing capabilities with Orion's commercial and regulatory expertise, focusing on one of immuno-oncology's most important medicines.

Partnership Scope and Roles​

Orion Corporation will serve as the Marketing Authorization holder, holding the exclusive right to register, market, distribute, and sell the nivolumab biosimilar across Europe. Shilpa Biologicals Private Limited will lead product development and act as the exclusive long-term commercial manufacturer and supplier for the European market from its advanced biologics facility in Dharwad, India.

The agreement entitles Shilpa to receive certain development and regulatory milestone payments from Orion, in addition to supply revenue over the life of the partnership.

Key aspects of the agreement include:

• Target Market: The biosimilar is intended for the European market.
• Product: Intravenous (IV) Nivolumab biosimilar, referencing a widely used cancer immunotherapy.
• Commercialization: Orion will be responsible for registration and sales across Europe.

Market Opportunity and Significance​

Nivolumab targets a substantial global immunotherapy market estimated at approximately USD 4.1 billion in 2025 (Source: IQVIA/IMS). This partnership is designed to put a high-quality, EU-GMP manufactured nivolumab biosimilar within reach of more patients and help health systems manage oncology budgets.

The deal extends the existing relationship between the companies, which previously collaborated on Shilpa’s Recombinant Human Albumin for Europe. The collaboration strengthens Shilpa’s end-to-end biologics development and manufacturing capabilities with Orion's established European distribution network and regulatory expertise.

Management Commentary​

Vishnukant Bhutada, Managing Director of Shilpa Medicare, stated that extending the partnership into immuno-oncology is a "defining moment" for Shilpa Biologicals. He added that it reflects the trust partners place in the company’s quality and science, moving closer to the mission of making advanced medicines affordable and accessible worldwide.

Satu Ahomäki, EVP Generics and Consumer Health at Orion Pharma, expressed satisfaction with the addition of the product. Mr Ahomäki noted that this agreement is a step toward expanding and strengthening Orion's operations in Continental Europe and reflects the progress of their strategy to provide access to affordable quality medicines.

Company Overview​

Shilpa Medicare Limited: Headquartered in India, Shilpa Medicare is a diversified pharmaceutical and biotechnology company involved in developing and manufacturing complex generics, biologics, and active pharmaceutical ingredients (APIs). Its subsidiary, Shilpa Biologicals Private Limited, operates an integrated biologics platform at its EU-GMP facility in Dharwad, India.

Orion Corporation: Orion Pharma is a Nordic pharmaceutical company with over one hundred years of experience. Their core therapy areas include oncology and pain management. In 2025, Orion’s net sales amounted to EUR 1,890 million, and the company employs approximately 4,000 professionals globally.

SHILPAMED Stock Price Movement​

Shares of Shilpa Medicare Limited surge to hit a 52-week high today, climbing 4.86% and trading at ₹601.45 as of 10:30 AM. This ascent is supported by brisk activity in the market, with 709,210 shares exchanged so far this morning.