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Positions Orion for Europe's Opdivo biosimilar wave; economics undisclosed and approval-gated
Full analysis, sources & comparables →Orion Pharma announces agreement with Shilpa Medicare (subsidiary Shilpa Biologicals) for an intravenous nivolumab biosimilar for the European market; Orion…
Legal/IP analysis of the Orion-Shilpa nivolumab biosimilar partnership for Europe, noting the expansion of an existing recombinant human albumin supply…
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Orion Corporation and Shilpa Medicare's wholly owned subsidiary Shilpa Biologicals expanded their partnership with a co-development and supply agreement for an intravenous nivolumab biosimilar for Europe, announced July 6, 2026. Orion holds exclusive rights to register, market, distribute and sell the biosimilar across Europe and will act as Marketing Authorisation holder, while Shilpa Biologicals leads product development and serves as the exclusive long-term manufacturer and supplier from its EU-GMP biologics facility in Dharwad, India. Shilpa is entitled to development and regulatory milestone payments plus supply revenue over the life of the partnership; specific financial terms were not disclosed. The partnership targets a European market opportunity of approximately $4.1B based on 2025 reference-product sales as Opdivo approaches loss of exclusivity.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| Orion Corporation / Shilpa Biologicals Private Limited (this deal) | 2026 | — | 52 |
| AstraZeneca PLC / Daiichi Sankyo Company, Limited | 2019 | $6.9B | 100 |
| Novartis AG / Endocyte, Inc. | 2018 | $2.1B | 96 |
| Astellas Pharma Inc. / Seagen Inc. | 2009 | $4.5B | 95 |
| Bristol-Myers Squibb Company / Medarex Inc. | 2009 | $2.4B | 92 |
| Servier SA / Agios Pharmaceuticals (oncology) | 2020 | $2.0B | 91 |
| Servier Pharmaceuticals LLC / Agios Pharmaceuticals Inc. | 2020 | $2.0B | 91 |
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