Sandoz signs global licensing agreement with Henlius to commercialise biosimilar ipilimumab for oncology use
Wednesday, April 30, 2025
Sandoz, a global leader in generic and biosimilar medicines, has entered a worldwide collaboration and licensing agreement with Shanghai Henlius Biotech, Inc. (Henlius) to commercialise a biosimilar version of ipilimumab, a widely used oncology therapy.
The agreement, valued at up to USD 301 million, includes an upfront payment of USD 31 million. It is based on milestones and aims to address a reference medicine market valued at approximately USD 2.5 billion.
Under the terms of the agreement, Sandoz will hold exclusive rights to commercialise the ipilimumab biosimilar in key markets including Australia, Canada, Europe, Japan and the United States. The core patent for ipilimumab has already expired in the US (March 2025) and is expected to expire in the EU by February 2026.
Ipilimumab is a monoclonal antibody that targets CTLA-4 and is used to treat several cancers, including colorectal cancer, esophageal cancer, liver cancer (hepatocellular carcinoma), malignant pleural mesothelioma, melanoma, non-small cell lung cancer, and kidney cancer (renal cell carcinoma).
Henlius is currently conducting an integrated Phase I/III clinical trial for its proposed ipilimumab biosimilar in patients with unresectable hepatocellular carcinoma, with a target of enrolling 656 participants (NCT06841185).
In parallel, Sandoz is developing a biosimilar of nivolumab, another monoclonal antibody that targets PD-1. This medicine is used either alone or in combination with other treatments for more than ten cancer types. A clinical trial is underway in advanced melanoma with a goal of enrolling 720 patients (NCT06587451). The combination of nivolumab and ipilimumab is approved for several indications including melanoma, mesothelioma, renal cell carcinoma, colorectal cancer, esophageal cancer, non-small cell lung cancer, and hepatocellular carcinoma.
Sandoz continues to expand its global biosimilar portfolio and has recently become the third-largest biosimilar provider in the US. The company’s pipeline includes 28 biosimilar candidates and around 450 generic medicines, supporting its long-term growth strategy. Its marketed oncology biosimilars include Rixathon®, Zarzio®, Ziextenzo®, and Binocrit®.
Sandoz also plans to launch its denosumab biosimilars, Wyost® and Jubbonti®, in the US during the second quarter of this year and in Europe by the fourth quarter.
Source: globenewswire.com
