Sandoz, the global leader in affordable medicines, has announced a major development, manufacturing and commercialisation collaboration agreement with Shanghai Henlius Biotech, Inc., marking another significant step towards broadening patient access to high-quality biosimilar medicines worldwide. The biosimilar collaboration deal will enable the two companies to work together on up to 10 biosimilars, with an initial bundle of assets already agreed.
Under the terms of the agreement, Sandoz will hold global commercialisation rights for the agreed biosimilar assets outside China, while Henlius will be responsible for development and manufacturing. The collaboration agreement is milestones-based for a total consideration of up to USD 322 million, with near-term payments associated with the initial assets that could reach up to USD 100.5 million.
Initial Assets Include Oncology and Cardiovascular Biosimilars
Richard Saynor, Chief Executive Officer, Sandoz, says, “Expanding access to life-enhancing medicines for patients around the world lies at the heart of everything we do. By strengthening our collaboration with Henlius through this strategic agreement, one of our largest ever in biosimilars, we are not only underlining our commitment to patients but also taking another step towards capturing a significant share of the unprecedented biosimilar market opportunity that lies ahead.”
One of the initial assets covered by the biosimilar collaboration deal is a proposed cetuximab biosimilar, which is currently in clinical development. The reference medicine, Erbitux® (cetuximab), is an epidermal growth factor receptor-targeted oncology therapy used to treat selected patients with metastatic colorectal cancer and squamous cell carcinoma of the head and neck. Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer death worldwide.According to the latest estimates, close to one million new cases of head and neck cancer are reported annually.
The agreement also includes a proposed evolocumab biosimilar for patients with hypercholesterolaemia and for reducing the risk of major cardiovascular events in adults at increased cardiovascular risk. A proposed belimumab biosimilar is also included and is intended for the treatment of active systemic lupus erythematosus in adults and children and active lupus nephritis in eligible patients, in addition to standard therapy.
Pipeline Expansion Strengthens Existing Partnership
The collaboration further provides an option for recombinant human hyaluronidase to be used in developing a subcutaneously administered biosimilar. This product increases the dispersion and absorption of other injected medicines. The proposed evolocumab biosimilar and recombinant human hyaluronidase are in technical development, while belimumab is in early development. Overall, the biosimilar collaboration deal expands the industry-leading Sandoz biosimilar pipeline to 39 assets, with the potential to increase to up to 46.
It represents another milestone in the company’s strategy to capitalise on a significant share of the unprecedented global biosimilar loss-of-exclusivity market over the next decade. The latest agreement also builds on the existing collaboration between the two companies, first established in April 2025 through a global collaboration agreement for oncology therapy ipilimumab. Sandoz continues to expand its industry-leading pipeline of biosimilar medicines, building on its experience as the pioneer and global leader with a portfolio of 13 molecules available in nearly 100 countries.
