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.
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.