What are the biosimilars of Herceptin?
Herceptin (trastuzumab) is the original brand of trastuzumab, a biological medicine used to treat specific types of breast and gastric cancer, in specific patients and used in conjunction with prescribed treatment regimes.
What is the difference between generic and biosimilar medicines?
- A biosimilar medicine is a copy of the original brand of biological medicine eg Ogivri is biosimilar of Herceptin.
- A generic medicine is a copy of the original brand of small molecule drug eg Wal-Itin is a generic of Claritin.
The biosimilars of Herceptin are:
Table comparing Herceptin to its Biosimilars
| Brand name | Herceptin | Herzuma | Kanjinti | Ogivri | Ontruzant | Trazimera |
| Active ingredient name | trastuzumab | trastuzumab-pkrb | trastuzumab-anns | trastuzumab-dkst | trastuzumab-dttb | trastuzumab-qyyp |
| Company | Genentech | Celltrion |
Allergan Amgen |
Mylan | Samsung Bioepis | Pfizer |
| Approval date (FDA) | 25 September 1998 | 14 December 2018 | 13 June 2019 | 1 December 2017 | 18 January 2019 | 11March 2019 |
| Interchangeable? | No | No | No | No | No | No |
| Treatment* |
Adjuvant breast cancer, Metastatic breast cancer, Metastatic gastric cancer |
Adjuvant breast cancer, Metastatic breast cancer, Metastatic gastric cancer |
Adjuvant breast cancer, Metastatic breast cancer, Metastatic gastric cancer |
Adjuvant breast cancer, Metastatic breast cancer, Metastatic gastric cancer |
Adjuvant breast cancer, Metastatic breast cancer, Metastatic gastric cancer |
Adjuvant breast cancer, Metastatic breast cancer, Metastatic gastric cancer |
| Form |
150mg Single use vial, 420mg Multiple use vial |
150mg Single use vial, 420mg Multiple use vial |
150mg Single use vial, 420mg Multiple use vial |
150mg Single use vial, 420mg Multiple use vial |
150mg Single use vial, 420mg Multiple use vial |
150mg Single use vial, 420mg Multiple use vial |
| Administration route | intravenous infusion | intravenous infusion | intravenous infusion | intravenous infusion | intravenous infusion | intravenous infusion |
* Treatment is only indicated in these conditions for selected patients who have a specific type of cancer, who will be using specific treatment regimens, and patient selection can be dependent on previously used treatment options
Related questions
- What are monoclonal antibodies?
- What are biosimilar drugs and how do they compare to biologics?
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What is a biological medicine?
- A biological medicine is a medicine that is made with biotechnology in a living cell or microorganism.
- Compared to a small molecule drug, biological medicines are much larger and more complex.
What is a reference product?
- When a new type of biological medicine is introduced it is called the reference product. If another company wants to copy it, the copied brand is called a biosimilar.
- Herceptin in the reference product.
What does biosimilar mean?
- There will always be slight differences between the copied brand (biosimilar) and the reference product because biological medicines are so complex.
- A biosimilar is highly similar to the reference product and the FDA states that it “has no clinically meaningful differences from an existing FDA-approved reference product”.
- So the biosimilar medicine is expected work the same as the reference product.
- The biosimilars of Herceptin are Herzuma, Kanjinti, Ogivri, Ontruzant and Trazimera
What does ‘interchangeable product’ mean?
- An interchangeable biosimilar is a biosimilar medicine that has been tested to meet extra requirements by the Biologics Price Competition and Innovation Act.
- This means that when the biological medicine is prescribed you may be given any biological medicine that is interchangeable with the reference product, and the prescriber does not need to be involved.
The biosimilars of Herceptin and NOT interchangeable.
References
- Biosimilar and Interchangeable Products: https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products#generic
- Herceptin Medication information: https://www.drugs.com/pro/herceptin.html
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How long can you stay on Herceptin and Perjeta?
If you are receiving Perjeta for treatment of HER2+ early breast cancer, you may continue treatments with Herceptin every 3 weeks for one year (18 cycles total). For the treatment of HER2+ metastatic breast cancer, you will receive Perjeta and Herceptin until the medicine no longer controls your breast cancer or you have side effects that require you to stop treatment. You may receive other treatments with these medications. Continue reading
What happens after Herceptin treatment?
After Herceptin treatment, your doctor will monitor you regularly for cancer progression, advise you not to become pregnant for at least 7 months (if you are of childbearing potential), and test your heart every 6 months for at least 2 years, because there is a higher risk of developing long-term heart damage in people who take Herceptin. Continue reading
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