Biocon withdraws its application for breast cancer medicines, shares dip
NEW DELHI: B io con Ltd share stumbled on Wednesday after the drug maker with drew applications for approval of two biosimilars used to treat breast cancer, citing European regulatory requirements. B io con shares closed 5.9% lower at ₹328.80 on the BSE after falling 7.54% in the session. The benchmark Sen sex rose 1.02% to close at 31,770.89 points.
Th eBengaluru-based pharma firm withdrew applications for th eb io similars Trastuzuma band Pegfilgrastim, drugs for breast cancer.
“Whilst 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,” a Biocon spokesperson said. “The request for withdrawal of the dossiers andre-submission is part of the European Medicines Agency (EM A) procedural requirements linked to this re-inspection and will be considered by the EMA’s Committee for Medicinal Products for Human Use.”
Biocon has developed the biosimilars—copies of biologic drugs—in collaboration with US drug maker Mylan.
Last month, the company’s stock gained strongly on expectations of regulatory approval for the biosimilars after the US Food and Drug Administration’s On co logic Drugs Advisory Committee (ODAC) recommended approval of the Mylan and Biocon’s trastuzumab.
Developed originally by Roche Holding AG, Tr astuzu ma bis one of the most commonly used drugs to treat HER 2- positive breast cancer.
The Swiss company’s drug is sold under the brand Herceptin worldwide and Herclon in India.
“We are on track to complete our corrective and preventive actions by the end of this quarter and it is our intent to seek re-inspection and re-submission thereafter,” said the Biocon spokesperson.