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Biocon today said it has requested for withdrawal of the dossiers for biosimilars — Trastuzumab and Pegfilgrastim — as part of the procedural requirements for re-inspection by the European regulator EMA.
“While our drug substance facilities for Trastuzumab and Pegfilgrastim were approved, the European regulatory authorities had informed us of the need for a re-inspection of our drug product facility for these products,” the bio-pharmaceutical firm said in a regulatory filing.
The request for withdrawal of the dossiers and re-submission is part of the European Medicines Agency’s (EMA) procedural requirements linked to this re-inspection and will be considered by the EMA’s Committee for Medicinal Products for Human Use (CHMP), the statement added.
“We are on track to complete our corrective and preventive actions (CAPAs) by the end of this quarter and it is our intent to seek re-inspection and re-submission thereafter,” spokesperson said.
Shares of Biocon declined 6.34 per cent to Rs 327.05 in afternoon trade on the BSE.
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