USFDA gives green signal to Biocon's biosimilar for Trastuzumab, stock up 10%
DSIJ Intelligence / 04 Dec 2017
In a significant development for Biocon, the Trastuzumab US drug regulator has approved the first biosimilar, Ogivri, developed by Mylan and Biocon for the treatment of HER2-Positive cancers.
In a significant development for Biocon, the Trastuzumab US drug regulator has approved the first biosimilar, Ogivri, developed by Mylan and Biocon for the treatment of HER2-Positive cancers.
Trastuzumab is a biosimiliar for Herceptin, certain HER2-positive breast and gastric cancers are treated with Trastuzumab, while Pegfilgrastim is used in the treatment of neutropenia in patients undergoing chemotherapy.
Earlier, on Friday, the company had informed that European drug regulator had accepted for review Mylan's Marketing Authorization Application (MAA) for the biosimilar Trastuzumab and Pegfilgrastin for breast cancer and chemotherapy drug.
This USFDA approval bodes well for the Biocon's image in the global pharma industry as a company with significant drug research and development capabilities. On Friday, the stock of Biocon closed at Rs. 446.55 per share, up 3.31. While in the pre-opening trading session on Monday, the stock was at Rs. 491.20, up by 10.00 per cent
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