FDA gives Celltrion, Teva green light for biosimilar Herceptin
Celltrion and Teva Pharmaceutical Industries have received clearance from the Food and Drug Administration for Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Genentech’s Herceptin (trastuzumab)
“Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provide more patients access to this important therapy,” Celltrion CEO Woosung Kee said. “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.”
The biosimilar is approved for the following indications:
“We are excited about building Teva’s presence in biosimilars,” Teva executive vice president and health of North America commercial Brendan O’Grady said. “The addition of Herzuma to our biosimilars portfolio will allow us to leverage our strengths from oncology and generics.”
“Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provide more patients access to this important therapy,” Celltrion CEO Woosung Kee said. “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.”
The biosimilar is approved for the following indications:
- Adjuvant breast cancer of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin.
- Metastatic breast cancer in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer; as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
“We are excited about building Teva’s presence in biosimilars,” Teva executive vice president and health of North America commercial Brendan O’Grady said. “The addition of Herzuma to our biosimilars portfolio will allow us to leverage our strengths from oncology and generics.”