Cetuximab

The Henlius linkup marks one of the largest biosimilar partnering agreements in Sandoz’s history. Credit: OleksSH/Shutterstock.com. Sandoz has entered a collaboration agreement with Shanghai Henlius Biotech that will see the two companies work together on a slew of new biosimilars. The deal is milestones-based for a total consideration of up to $322m, with near-term payments associated with the initial assets that could reach up to $100.5m. Under the agreement, the two companies will collaborate on up to 10 biosimilars, with an initial group of assets already agreed. Henlius will develop and manufacture the assets, with Sandoz then taking on commercialisation rights across the world, bar China. The wide-arching agreement marks a continuation of work between the two companies that first started in April last year in an oncology-centric deal. The new batch includes a biosimilar to Erbitux (cetuximab), Eli Lilly and Merck KGaA’s antibody for colorectal cancer and forms of squamous cell carcinoma. The drug’s global sales grew 6.6% to reach $1.7bn in 2025. While its core patents have expired for some time, no biosimilars have been marketed due to the compound’s structural complexity. Sandoz and Henlius will also work on a biosimilar referencing Amgen’s cholesterol-lowering drug Repatha (evolocumab) and GSK’s lupus drug Benlysta (belimumab). A recombinant human hyaluronidase that can be used while developing a subcutaneously administered biosimilar to increase the dispersion and absorption of other injected medicines is in technical development. Sandoz CEO, Richard Saynor, said: “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.” In a research note, Jefferies analysts called the Henlius link-up “one of the largest biosimilar partnering agreements in Sandoz’s history”, with the analysts adding that they “expect further in-licensing activity [at the company] to fill an upcoming industry pipeline void”. Sandoz, generally recognised as the world’s largest biosimilar and generics company, already had a widespread pipeline. The Henlius collaboration only adds to that, with the Swiss company’s biosimilar pipeline now standing at 39 assets, and the potential to increase to up to 46. The pair-up comes at a time of significant opportunity in the prescription drug industry as the sector approaches one of the largest ongoing patent cliffs in its history. A 2025 report by GlobalData projected that the share of global drug sales under patent protection will be only 4% in 2030, compared to 12% in 2022. GlobalData is the parent company of Pharmaceutical Technology . While big pharma companies are contending with revenue voids, Sandoz could be set for a period of high growth. In a statement announcing the Henlius deal, Sandoz said it “represents another milestone in [its] strategy to capitalise on a significant share of the unprecedented global biosimilar loss-of-exclusivity market over the next decade”.

Sandoz has announces a major development, manufacturing and commercialisation collaboration agreement with Shanghai Henlius Biotech, marking another significant step to broaden patient access to high-quality biosimilar medicines worldwide. The agreement paves the way for the two companies to collaborate on up to ten biosimilars, with an initial bundle of assets already agreed. Under its terms, Sandoz will have global commercialisation rights for 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 $322m, with near-term payments associated with the initial assets that could reach up to $100.5m. Richard Saynor, CEO of Sandoz, said: “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 under the agreement will be a proposed cetuximab biosimilar, which is 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, while close to one million new cases of head and neck cancer are reported annually, according to the latest estimates. In addition, the collaboration also covers a proposed evolocumab biosimilar used in patients with hypercholesterolaemia and for reducing the risk of major cardiovascular events in adults at increased cardiovascular risk, and a proposed belimumab biosimilar 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. There is also an option for a recombinant human hyaluronidase to be used in the development of a subcutaneously administered biosimilar, which 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 collaboration expands Sandoz’s biosimilar pipeline to 39 assets, with the potential for that to increase to up to 46, and builds on the existing collaboration between the two companies, first established in April 2025 through a global collaboration agreement for oncology therapy ipilimumab.