Mylan and Biocon announced that US Food and Drug Administration (FDA) have approved Mylan’s Ogivri, a biosimilar to Herceptin, co-developed with Biocon.
“Ogivri has been approved for all indications 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,” Biocon said in a statement.
In the US an estimated 250,000 new cases of female breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed in 2017 alone. Approximately 20% to 25% of primary breast cancers are HER2-positive.
Herceptin had US sales of more than $2 billion for the 12 months ending September 30, 2017, according to IQVIA.
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