FDA OKs Teva's, Celltrion’s Biosimilar of Roche’s Herceptin

By Patricia Van Arnum - DCAT Editorial Director

January 3, 2019

The US Food and Drug Administration (FDA) has approved Herzuma (trastuzumab-pkrb), a biosimilar to Roche’s Herceptin (trastuzumab) from Teva Pharmaceutical Industries and Celltrion, an Incheon, South Korea-based pharmaceutical company. Herceptin had 2017 global sales of CHF 7.01 billion ($7.5 billion).

Herzuma has been 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; 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.

Teva and Celltrion entered into an exclusive partnership in October 2016 to commercialize Herzuma in the US and Canada.

This marks the second recent biosimilar approval for Teva and Celltrion. In November 2018, Teva and Celltrion received FDA approval of biosimilar, Truxima (rituximab-abbs), which references Roche’s Rituxan (rituximab), a drug to treat certain cancers and autoimmune diseases. Rituxan had 2017 global sales of CHF 7.3 billion ($7.8 billion).

Source: Celltrion and Teva Pharmaceutical Industries