What is the difference between Herzuma and Herceptin?
Does biosimilar mean they are exactly the same?
Herzuma (trastuzumab-pkrb) is a biosimilar to Herceptin (trastuzumab).
According the to FDA, a biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.
The FDA approval for Herzuma was based on the results of clinical studies which demonstrated that there were no clinically meaningful differences in purity, potency and safety between Herzuma and Herceptin for the treatment of HER2-overexpressing breast cancer.
Herzuma is the second approved biosimilar to Herceptin. The first biosimilar to Herceptin was Ogivri (trastuzumab-dkst) approved in December 2017.
The indications, dosage forms and strengths for Herceptin and Herzuma are summarized below:
Herceptin (trastuzumab) for Injection
Company: Genentech, Inc.
Date of Approval: September 25, 1998
Dosage Form: lyophilized powder for reconstitution
Strengths: 150 mg (single-dose vial) and 420 mg (multiple-dose vial)
Herceptin is indicated for:
- the treatment of HER2-overexpressing breast cancer.
- the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
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Herzuma (trastuzumab-pkrb) for Injection
Company: Celltrion, Inc. and Teva Pharmaceutical Industries Ltd.
Date of Approval: December 14, 2018
Dosage Form: lyophilized powder for reconstitution
Strength: 150 mg (single-dose vial) and 420 mg (multiple-dose vial)
Herzuma is indicated for:
- the treatment of HER2-overexpressing breast cancer.
- the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
For more information on other Herceptin biosimilars, see What are the biosimilars of Herceptin?
Read next
What is TCHP chemotherapy and how is it used?
TCHP is a combination of Taxotere (docetaxel), carboplatin (Paraplatin), Herceptin (trastuzumab), Perjeta (pertuzumab). It is used to treat early-stage HER2-positive breast cancer.
Continue reading
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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Drug information
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