On 30 June 2026, Nordic-based Orion Pharma announced it has entered into an agreement with India-headquartered Shilpa Biologicals, a subsidiary of Shilpa Medicare, to commercialise in Europe Shilpa’s intravenous nivolumab biosimilar, which is currently under development.
Under the agreement, Orion will have the exclusive right to distribute, market and sell Shilpa’s biosimilar nivolumab in Europe, while Shilpa will supply the product to Orion and is entitled to receive certain confidential development and regulatory milestone payments.
BMS’ originator nivolumab (Opdivo®) is approved in Europe for various indications including:
- classical Hodgkin Lymphoma in combination with doxorubicin, vinblastine and dacarbazine (AVD) and in combination with brentuximab vedotin;
- resectable non-small cell lung cancer;
- unresectable or advanced hepatocellular carcinoma in combination with Yervoy® (ipilimumab);
- MSI-H or dMMR unresectable or metastatic colorectal cancer in combination with Yervoy®
- melanoma; and
- metastatic gastric, gastroesophageal junction, or oesophageal adenocarcinoma.
A number of other nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.
Orion has an existing distribution agreement for Europe with CuraTeQ in relation to unidentified biosimilars, while Shilpa announced a commercialisation deal with SteinCares for an undisclosed biosimilar in Latin America in February 2026.