Herceptin is a monoclonal antibody that binds to the human epidermal growth factor receptor 2 positive (HER2) receptors to prime them for being targeted by the immune system. It has been approved for the treatment of HER2-positive breast cancer and metastatic gastric cancers. Herceptin generated Sfr878m ($980m) in global sales in H1 2023, as per Roche’s Q2 2023 financial report.
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The Herceptin biosimilar was developed by EirGenix and is licensed by SandozSandoz. While EirGenix holds the developmental and manufacturing rights, Sandoz is responsible for the commercialisation of the biosimilar.
The CHMP recommendation is based on the Phase I and III studies in patients with breast cancer showing that the biosimilar is non-inferior to the reference biologic.
The difference in sales is partly driven by the US reimbursement system which often prioritises the reference biologic over the biosimilars, along with the substantially low cost of biosimilars.
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