Herceptin generated Sfr878m ($980m) in global sales in H1 2023, as per Roche’s Q2 financial report. Image Credit: Panaceum Media / Shutterstock.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.