Biocon withdraws application for breast cancer biosimilars, shares fall

August 17, 2017, Teena Thacker

Biocon Ltd shares tumbled on Wednesday after the drug maker withdrew applications for approval of two biosimilars used to treat breast cancer, citing European regulatory requirements.
Biocon shares closed 5.9% lower at Rs328.80 on the BSE after falling as much as 7.54% in the session. The benchmark Sensex rose 1.02% to close at 31,770.89 points.
The Bengaluru-based pharma firm withdrew applications for the biosimilars Trastuzumab and 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 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.”
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 Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Mylan and Biocon’s trastuzumab.
Developed originally by Roche Holding AG, Trastuzumab is one of the most commonly used drugs to treat HER2-positive breast cancer. The Swiss company’s drug is sold under the brand Herceptin worldwide and Herclon in India.
A report from HSBC on Wednesday said the withdrawal of applications indicates a delay in the launch of the drugs. Biocon along with partner Mylan were the first ones to receive approval to market Transtuzumab from the EMA in August 2016.

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