About Herzuma
Herzuma (trastuzumab biosimilar) is a prescription only medicine. Herzuma powder for intravenous infusion is available as:
– Herzuma 150 mg vial containing 150 mg of trastuzumab
– Herzuma 440 mg vial containing 440 mg of trastuzumab
Herzuma is a biosimilar medicine to the reference biological medicine Herceptin. A biosimilar is a biological medicinal product that is highly similar to an already licensed biological medicinal product (reference product). 1-3 In the case of trastuzumab, the reference product is Herceptin. A biologic is a medicinal product that is derived from living organisms including humans, animals or microorganisms, and is used in treating many life-threatening and chronic diseases. 1,4
Small differences occur because biological medicinal products are large, highly complex molecules derived from living organisms.
These differences are similar to the differences that can occur between batches of a reference biological product. 5
Despite these small differences, biosimilar medicines are expected to be as safe and effective as the reference biological product. 5
HERZUMA is a biosimilar of Herceptin. The active substance in Herzuma, trastuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the HER2 protein on the surface of target cells. By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells. Trastuzumab also stops HER2 producing signals that cause the tumour cells to grow. 6
What is Herzuma used to treat? 7
Herzuma is used to treat adult patients with HER2-positive:
• Early breast cancer
• Metastatic breast cancer
• Advanced stomach cancer or gastro-oesophageal cancer
If you experience any side effects or experience any discomfort during your treatment period, please speak to your doctor, pharmacist or healthcare professional.
Herzuma has risks and benefits. Always discuss your condition and treatment plan with your healthcare professional and ask your doctor if Herzuma is right for you. If you have any questions, please seek the advice of your healthcare provider.
This medicine is subjected to additional monitoring to allow quick identification of new safety information. You can help by reporting any side effects you may get at the following contact channels.
Phone: 0800 838 899
Email: medinfo-nz@celltrionhc.com
Additional Data Sheets and Consumer Medicine Information can be obtained from the Medsafe website at https://www.medsafe.govt.nz/medicines/infosearch.asp
References
1. World Health Organization. Expert committee on biological standardization sixtieth report. Annex 2 – Guidelines on evaluation of similar biotherapeutic products (SBPs). WHO Technical Report Series No.977, 2013. Available at: https://www.who.int/publications/m/item/sbp-trs-977-Annex-2 Accessed November 2023.
2. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015 Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product. Accessed November 2023.
3. European Medicines Agency. CHMP/437/04 Rev 1 Guideline on similar biological medicinal products. 2014. Available at: https://www.ema.europa.eu/system/files/documents/scientific-guideline/wc500176768_en.pdf. Accessed November 2023.
4. U.S. Food and Drug Administration. What are biologics questions and answers. 2018. Available at: https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers. Accessed November 2023.
5. Pharmac | New Zealand. Biological and Biosimilar Medicines. February 17, 2023. Accessed September 22, 2023. https://pharmac.govt.nz/medicine-funding-and-supply/what-you-need-to-know-about-medicines/biological-and-biosimilar-medicines/#:~:text=Biosimilars%20reduce%20costs%20for%20the,compete%20with%20the%20reference%20medicine.
6. Herzuma SmPC. (2022). Available at: https://www.medicines.org.uk/emc/files/pil.9864.pdf Accessed Feb 2023.
7. Herzuma Medsafe Product Detail. (2019) Available at: https://www.medsafe.govt.nz/regulatory/ProductDetail.asp?ID=19078 Accessed Sept 2023.