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What are the biosimilars of Herceptin?

Medically reviewed by Melisa Puckey, BPharm. Last updated on Aug 20, 2020.

What are the generics of Herceptin?

Official Answer

by Drugs.com

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

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.

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