Sandoz and Shanghai Henlius Biotech have entered into a major collaboration to develop, manufacture and commercialize biosimilar medicines, with the aim of expanding access to affordable treatments worldwide.
Under the agreement, the companies will work together on up to 10 biosimilar medicines. Sandoz will hold global commercialization rights for the agreed products outside China, while Henlius will lead their development and manufacturing.
The milestone-based agreement has a total potential value of up to $322 million. Near-term payments linked to the initial group of assets could reach up to $100.5 million.
Richard Saynor, CEO of Sandoz, said the agreement strengthens the company’s commitment to improving access to medicines and supports its plans to capture a larger share of the growing global biosimilar market.
One of the initial products covered by the agreement is a proposed cetuximab biosimilar, which is currently in clinical development. Cetuximab is used in certain patients with metastatic colorectal cancer and squamous cell carcinoma of the head and neck. The biosimilar is intended to provide another treatment option as demand for more affordable oncology medicines continues to grow.
The collaboration also includes a proposed evolocumab biosimilar. Evolocumab is used to treat high cholesterol and help reduce the risk of major cardiovascular events in adults who have an increased cardiovascular risk. The product is currently in technical development.
Another asset is a proposed belimumab biosimilar, which is being developed for patients with active systemic lupus erythematosus and lupus nephritis. Belimumab is currently in early development under the collaboration.
The companies also have an option covering recombinant human hyaluronidase. This enzyme can help improve the dispersion and absorption of medicines given by subcutaneous injection and could support the development of future biosimilar products.
The agreement expands Sandoz’s biosimilar pipeline to 39 assets, with the potential to increase the total to 46. Sandoz is one of the leading companies in the global biosimilars market, with 13 molecules already available across nearly 100 countries.
The new deal also builds on the companies’ existing relationship. Sandoz and Henlius first entered into a global collaboration in April 2025 focused on ipilimumab, an oncology medicine.
Sandoz said the latest agreement supports its strategy to benefit from the growing number of biologic medicines expected to lose market exclusivity over the coming decade. Biosimilars can help increase competition and provide patients and healthcare systems with more affordable alternatives to established biologic treatments.
For Henlius, the collaboration provides an opportunity to use its development and manufacturing capabilities to support the global expansion of its biosimilar portfolio. For Sandoz, the deal adds several potential products to an already broad pipeline and strengthens its position in key therapeutic areas, including oncology, cardiovascular disease and autoimmune conditions.
The companies expect the collaboration to support the development and availability of additional biosimilar medicines in markets outside China, potentially giving more patients access to lower-cost biological treatments.