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New Drugs approved in December

Ogivri
Ogivri

Ogivri (trastuzumab-dkst) received green signal from the FDA on December 1, 2017, for the treatment of patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene.

Developed by Mylan GmbH, along with India's Biocon Ltd., Ogivri is a biosimilar to Genentech, Inc.'s Herceptin (trastuzumab), which was approved in September 1998.

According to IQVIA, Herceptin had U.S. sales of more than $2 billion for the 12 months ending September 30, 2017. A kit of Herceptin costs around $3,500.

Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.

In September 2017, Amgen Inc.'s (AMGN) Mvasi gained FDA approval as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer.

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