The initial batch of biosimilars includes copies of Amgen, Eli Lilly and GSK drugs that collectively generate billions of dollars in annual revenues.
Sandoz has agreed to pay up to $322 million to collaborate with Shanghai Henlius Biotech on up to 10 biosimilars.
The deal gives Sandoz ex-China rights to the biosimilars, starting with copies of Amgen’s Repatha (evolocumab), Eli Lilly’s Erbitux (cetuximab) and GSK’s Benlysta (belimumab). Sandoz also has an option on a recombinant human hyaluronidase called rHuPH20. Henlius recently began clinical trials of the enzyme. Elsewhere, U.S. biotech Halozyme is using recombinant human hyaluronidase to enable subcutaneous delivery of intravenous drugs.
Near-term payments associated with the initial assets could reach $100.5 million. Sandoz has the chance to add more biosimilars to the collaboration, up to the maximum deal size of 10 drugs and $322 million in initial fees and milestone payments.
China’s Henlius will handle development and manufacturing. The drugmaker has three manufacturing sites in China with a total capacity of 84,000 liters. European authorities have certified all of the plants. Two of the facilities, with a combined capacity of 60,000 liters, are good manufacturing practice-certified by U.S. regulatory agencies. The sites supply China, North and Latin America, Europe and Southeast Asia.
The Chinese drugmaker has begun clinical development of the Erbitux biosimilar. The cancer medicine lost patent protection years ago but has remained free from biosimilar competition, an anomaly that researchers have linked to the antibody’s “unique structural complexity.” In 2024, the last year that Lilly disclosed Erbitux sales, the product generated $627.4 million worldwide, up 5% year-on-year.
Henlius’ proposed Repatha and Benlysta biosimilars could give Sandoz copies of blockbuster treatments for certain cardiovascular conditions and systemic lupus erythematosus, respectively. Sales of Amgen’s Repatha hit $3 billion last year, while Benlysta generated £1.8 billion ($2.4 billion) for GSK.
The Repatha and Benlysta biosimilars are in technical and early development, respectively. Amgen lists U.S. and European Repatha patents that expire between 2028 and 2033. GSK has Benlysta patents that expire as late as 2035.
Following the deal, Sandoz’s biosimilar pipeline features 39 assets. The pipeline supports an increasingly important business for Sandoz, which reported 22% growth in biosimilar sales in the second quarter. The growth, coupled with the flatlining of Sandoz’s larger generics business, resulted in biosimilars accounting for one-third of total sales in the quarter.
Upcoming patent expirations on blockbuster biologics give Sandoz and its biosimilar rivals opportunities to grow further in the coming years. Led by Merck’s Keytruda, products with sales of about $180 billion are set to lose patent protection in 2027 and 2028.
