Biocon remains in the red
Biocon continues to fall today too. Figuring amongst the top five losers on the BSE, slipping over 3% to Rs.318.85. It has recovered since then but remains in the red.
The company stated that it has withdrawn applications for approval of two biosimilars used to treat breast cancer, mainly on account of European regulatory needs.
The company said that though its drug substance facilities for Trastuzumab and Pegfilgrastim were approved, the European regulatory authorities had informed it the need for a re-inspection of our drug product facility for these products.
The request for withdrawal of the dossiers and re-submission is part of the European Medicines Agency procedural requirements linked to this re-inspection and will be considered by the EMA’s Committee for Medicinal Products for Human Use.