Biocon Ltd. has withdrawn its application seeking European Union approval for two drugs after the EU drugs’ regulator sought reinspection of their production facility, sending shares down more than 8% intraday.
Biocon will resubmit the applications for breast cancer drug Trastuzumab and Pegfilgrastim, which cuts infection risk in patients undergoing chemotherapy, after the European Medicines Agency completes the inspection, it said in a filing on Wednesday.
“The European regulatory authorities had informed us of the need for a reinspection of our drug product facility for these products,” Biocon said.
