In brief: Mylan’s trastuzumab biosimilar approved in US

Keytruda approved in China as country’s first anti-PD-1 therapy

Mylan has gained US FDA approval for Ogiviri, the biosimilar to Herceptin (trastuzumab) it co-developed with Biocon.

Specifically, it has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer.

Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the US.