Ogivri, a Biosimilar to Herceptin, Now Available in the US

Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab; Genentech) has been made available by Mylan and Biocon Biologics.

Ogivri, a HER2/neu receptor antagonist, is indicated for:

• Adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with 1 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; or as a single agent following multi-modality anthracycline based therapy.
• In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, and as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received 1 or more chemotherapy regimens for metastatic disease.
• In combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

The approval of Ogivri was based on data demonstrating that the biosimilar product is highly similar to the reference product, Herceptin. In addition, long-term data from the HERITAGE study, which compared Ogivri to Herceptin in patients with HER2+ metastatic breast cancer, showed similar median overall survival (35.0 months with Ogivri vs 30.2 months with Herceptin); treatment-emergent adverse events were found to be similar between the 2 groups as well. “The HERITAGE study had a unique trial design that not only evaluated objective response rate at week 24 as its primary end point but also assessed key end points including progression-free survival rate and overall survival at 36 months,” said Dr Hope S. Rugo, professor of medicine at the University of California, San Francisco, and lead author of the HERITAGE study. “The concordant efficacy data across all 3 endpoints conclusively demonstrated that Ogivri was similar to Herceptin, and patients without progression now continue on Ogivri as maintenance therapy.”

Ogivri is supplied in 420mg multi-dose vials as well as 150mg single-dose vials. 

For more information visit ogivrihcp.com.

This article originally appeared on MPR