Herzuma, which is a HER2/neu receptor antagonist biosimilar to Herceptin, has been approved to treat HER2-overexpressing breast cancer for certain indications.
Celltrion CEO Woosung Kee said: “Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provide more patients access to this important therapy.
“This is our second oncology biosimilar approval in the United States in the past month, which reinforces the goal for all of our approved products — providing broader treatment options for patients and the providers who treat them.”
Herzuma was approved for indications, including adjuvant breast cancer of HER2 overexpressing node positive or node negative breast cancer.
It can be included in a treatment regimen that composed of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, as well as in the treatment regimen that includes docetaxel and carboplatin.
Herzuma can be used in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, and as a single agent to treat HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
Patients will be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product in the approved indications.
The FDA approval was based on the assessment of a data package, including foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy and safety data.
According to the company, the date from the clinical development program showed no clinically meaningful differences in purity, potency and safety between Herzuma and Herceptin to treat HER2-overexpressing breast cancer for the approved indications.
In October 2016, Celltrion entered into an exclusive partnership with Teva Pharmaceutical Industries to commercialize Herzuma in the US and Canada.
Teva North America commercial head and executive vice president Brendan O’Grady said: The addition of Herzuma to our biosimilars portfolio will allow us to leverage our strengths from Oncology and Generics.”