The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Sandoz’s Herceptin (trastuzumab) biosimilar for European marketing approval.

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.

The Herceptin biosimilar was developed by EirGenix and is licensed by Sandoz. 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.

In 2019, the US Food and Drug Administration (FDA) approved Amgen and Allergan’s Herceptin biosimilar, Kanjinti. The sales for the biosimilar pales in comparison to the Herceptin sales, with Amgen reporting $50m in sales for Q2 2023 for Kanjinti, as per the company’s Q2 financial report.

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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With Sandoz expected to break off from Novartis in early October, the Herceptin biosimilar will be added to Sandoz’s biosimilar catalogue. This includes the Tysabri (natalizumab) biosimilar for relapse-remitting multiple sclerosis (RRMS), and the Humira (adalimumab) biosimilar, Hyrimoz, for rheumatoid arthritis and other indications.

Earlier this month, Sandoz signed a licensing agreement with Samsung Bioepis to market Stelara biosimilar in Europe and North America.