South Korean manufacturer, Celltrion, and Israeli drugmaker, Teva Pharmaceutical Industries, have announced US regulatory approval of Herzuma (trastuzumab-pkrb) – a biosimilar version of Roche’s blockbuster cancer drug, Herceptin.
Herzuma (trastuzumab-pkrb) is a HER2/neu receptor antagonist 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.
Herzuma is the product of a 2016 agreement between Teva and Celltrion, to develop, manufacture and commercialise two biosimilars in the US and Canada: Roche’s Herceptin (trastuzumab) and Rituxan (rituximab).
The partnership has since experienced regulatory setbacks, including a US Food and Drug Administration (FDA) warning letter highlighting ‘multiple poor aseptic practices’ at Celltrion’s South Korean manufacturing facility, observed during an inspection in May and June of last year.
In April of this year, the FDA followed up with complete response letters for both Truxima and Herzuma.
Having now secured FDA approval for its Rituxan alternative, Truxima (rituximab-abbs), the partnership is celebrating its second success since November.
“This is our second oncology biosimilar approval in the US 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,” wrote Celltrion CEO, Woosung Kee, in a statement.
Neither a launch date nor expected list price have been disclosed. However, earlier this year Roche predicted a Herceptin biosimilar to launch in the US in the second half of 2019.
Herceptin landscape
Mylan and Biocon’s Ogivri is the only other biosimilar version of Roche’s Herceptin to have received FDA approval. Potential rival products have also been developed by Pfizer, Amgen, and Mylan.
Across the pond, Celltrion has partnered with Mundipharma to commercialise Herzuma in seven European countries: Germany, UK, Ireland, Belgium, the Netherlands, Italy and Luxembourg.
Mundipharma has also launched Celltiron’s versions of J&J’s Remicade (infliximab), Remsima, and Roche’s Mabthera (rituximab), Truxima, within Europe.