Highlights
- Shilpa Biologicals signed a co-development and supply agreement with Orion Corporation.
- The partnership covers an intravenous nivolumab biosimilar for the European market.
- Orion will exclusively commercialise the product across Europe.
Shilpa Medicare Ltd. (NSE:SHILPAMED) informed the National Stock Exchange (NSE) and BSE that its wholly owned subsidiary, Shilpa Biologicals Private Limited (SBPL), has entered into a co-development and supply agreement with Finland-based Orion Corporation.
The agreement relates to the development, manufacturing and supply of an intravenous (IV) nivolumab biosimilar, one of the world's widely used cancer immunotherapies. The disclosure was made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
Source: Analysis by Kalkine
Agreement Focuses on European Market
Under the agreement, Shilpa Biologicals will co-develop, manufacture and exclusively supply the intravenous nivolumab biosimilar for the European market. Orion Corporation will hold the exclusive rights to register, market, distribute and sell the product across Europe and will serve as the Marketing Authorisation Holder in the region. According to the company, the partnership combines Shilpa's manufacturing capabilities with Orion's commercial and regulatory expertise.
Manufacturing to Be Done in India
The company stated that Shilpa Biologicals will lead product development and act as the exclusive long-term commercial manufacturer and supplier for Europe from its biologics manufacturing facility in Dharwad, India.
As part of the agreement, Shilpa will be entitled to receive certain development and regulatory milestone payments from Orion, in addition to supply revenue throughout the partnership. The financial consideration under the agreement has not been disclosed and has been marked confidential.
Objective of the Partnership
According to the company, the partnership aims to expand patient access to a high-quality, EU-GMP-manufactured nivolumab biosimilar across Europe following the expected loss of exclusivity of the originator product. The company also noted that nivolumab recorded sales of approximately USD 4.1 billion in Europe during 2025, citing IQVIA/IMS data in its press release.
Management Commentary
Vishnukant Bhutada, Managing Director, Shilpa Medicare, said:
"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 — and it moves us closer to our mission of making advanced medicines affordable and accessible worldwide."
Satu Ahomäki, EVP Generics and Consumer Health, Orion Pharma, said:
"We are pleased to add yet another product to our strategic partnership with Shilpa. This agreement is a step forward in our efforts to expand and strengthen our operations in hospital segment in Continental Europe, and an indication of the progress of the implementation of our division’s strategy which aims to create everybody an access to affordable quality medicines."
Partnership Builds on Earlier Collaboration
The company stated that the latest agreement follows an earlier collaboration between Shilpa and Orion involving recombinant human albumin for the European market. According to the press release, the new agreement expands the relationship into the immuno-oncology segment.
Key Risks
- Product development may face regulatory approval delays.
- Biosimilar development involves clinical and technical execution risks.
- Commercial success depends on market acceptance in Europe.
- Manufacturing and supply timelines could affect commercialization.
Summary
Shilpa Medicare (NSE:SHILPAMED) announced that its wholly owned subsidiary, Shilpa Biologicals Private Limited, has entered into a co-development and supply agreement with Finland-based Orion Corporation for an intravenous nivolumab biosimilar. Shilpa will develop, manufacture and exclusively supply the product for Europe, while Orion will exclusively handle its registration, marketing, distribution and sales across the European market.
FAQs
Q: What agreement has Shilpa Biologicals signed with Orion Corporation?
A: Shilpa Biologicals signed a co-development and supply agreement for an intravenous nivolumab biosimilar targeting the European market.
Q: What are the responsibilities of Shilpa and Orion under the agreement?
A: Shilpa will develop, manufacture and supply the biosimilar, while Orion will exclusively register, market, distribute and sell it in Europe.
Q: Has Shilpa Medicare disclosed the financial value of the agreement?
A: No. The company stated that the financial consideration under the agreement is confidential.