Nature of Agreement

Shilpa Biologicals Private Limited (SBPL), a wholly owned subsidiary of Shilpa Medicare Limited, has entered into a co-development and supply agreement with Orion Corporation, a globally recognized pharmaceutical company headquartered in Finland.

Product and Market Focus

The agreement is for the co-development and supply of an intravenous (IV) Nivolumab biosimilar. Nivolumab is one of the world's most widely used cancer immunotherapies, and the partnership specifically targets the European market.

Roles and Responsibilities

Under the agreement:

  • Shilpa Biologicals will lead product development and serve as the exclusive long-term commercial manufacturer and supplier for the European market. Manufacturing will occur at its advanced biologics facility in Dharwad, India.
  • Orion Corporation will hold the exclusive right to register, market, distribute, and sell the Nivolumab biosimilar across Europe. Orion will act as the Marketing Authorization holder in the territory.

Financial Terms

Shilpa is entitled to receive from Orion:

  • Certain development and regulatory milestone payments.
  • Supply revenue over the life of the partnership.

The specific details of the consideration are confidential.

Strategic Rationale and Market Context

The partnership aims to leverage the loss of exclusivity of the originator Nivolumab to increase patient access to a high-quality, EU-GMP-manufactured biosimilar across Europe. In 2025, the European Nivolumab market recorded sales of approximately USD 4.1 billion (source: IQVIA/IMS), highlighting the significant market opportunity. The agreement combines Shilpa's manufacturing capabilities with Orion's commercial and regulatory expertise in Europe.

Management Commentary

  • Vishnukant Bhutada, Managing Director of Shilpa Medicare, stated: "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."
  • Satu Ahomäki, EVP Generics and Consumer Health at Orion Pharma, stated: "This agreement is a step forward in our efforts to expand and strengthen our operations in hospital segment in Continental Europe."

Related Party Status

Orion Corporation is confirmed not to be a related party to Shilpa Medicare Limited, SBPL, or its promoters/promoter group/group companies. The transaction is conducted at arm's length.