Ipilimumab is a monoclonal antibody that works to activate the immune system by targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), a protein receptor that down regulates the immune system [1]. 

The reference medicine can be used alone or with other medicines to treat certain types of colorectal cancer, esophageal cancer, hepatocellular carcinoma (a type of liver cancer), malignant pleural mesothelioma, melanoma, non-small cell lung cancer and renal cell carcinoma (a type of kidney cancer).

The core sequence patent for ipilimumab expired in March 2025 in the US and will expire no later than February 2026 in Europe.

The current Sandoz–Henlius agreement is milestone-based for a total consideration of up to US$301 million, including an upfront payment of US$31 million, and will target net reference-medicine sales of US$2.5 billion.

Under the terms of the agreement, Sandoz has exclusive commercial rights for a biosimilar of ipilimumab in Australia, Canada, Europe, Japan and the US. Henlius is to develop and manufacture the biosimilar, while Sandoz takes on registration and commercialization after expiry of relevant patents across global markets.

Combination therapy of ipilimumab and nivolumab used in 95% of eligible patients. As such, ipilimumab highly complementary to the proposed Sandoz nivolumab biosimilar currently undergoing an integrated Phase I/III study. Together, these medicines are indicated for the treatment of melanoma, malignant pleural mesothelioma, renal cell carcinoma, certain types of colorectal cancer, esophageal cancer, non-small cell lung cancer and hepatocellular carcinoma. The originator to nivolumab is Bristol Myers Squibb and Ono’s Optivo [2].

In 2022, Henlius entered into an agreement with Organon, granting licensing and commercialization rights for biosimilar candidates referencing Perjeta (pertuzumab), and Prolia/Xgeva (denosumab). Under the agreement, Organon will have global rights excluding China and its territories [3]. 

Meanwhile, competitor Innovent received acceptance from China’s NMPA’s for its New Drug Application on 24 February 2025, along with priority review of its ipilimumab injection–China’s first domestic CTLA-4 inhibitor. The drug is intended for use in combination with sintilimab as a neoadjuvant treatment for colon cancer. 

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Innovent starts phase II trial for ipilimumab copy biological

References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Innovent’s ipilimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 11]. Available from: www.gabionline.net/biosimilars/research/Positive-phase-I-results-for-Innovent-s-ipilimumab-copy-biological
2. GaBI Online - Generics and Biosimilars Initiative. Top nine biological drugs by sales in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 11]. Available from: www.gabionline.net/reports/top-nine-biological-drugs-by-sales-in-2023
3. GaBI Online - Generics and Biosimilars Initiative. Organon–Henlius partnership: biosimilars for women’s health [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 11]. Available from: www.gabionline.net/pharma-news/organon-henlius-partnership-biosimilars-for-women-s-health

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