Jan 12, 2017 09:44 AM IST IST | Source: Moneycontrol.com

Biocon at new high as USFDA accepts application for cancer drug

Biocon shares touched a record high of Rs 1,049.50 on Thursday, up nearly 5 percent intraday after the US health regulator has accepted biosimilar application for its proposed cancer drug.

Moneycontrol Bureau

Biocon shares touched a record high of Rs 1,049.50 on Thursday, up nearly 5 percent intraday after the US health regulator has accepted biosimilar application for its proposed cancer drug.

"The US Food and Drug Administration has accepted Mylan's biologics license application for MYL-14010, a proposed biosimilar Trastuzumab," the company said in its filing.

The proposed biosimilar Trastuzumab is indicated to treat certain HER2-positive breast cancers.

The company said anticipated FDA goal date set under the Biosimilar User Free Act was September 3, 2017.

"It is a major milestone for the Mylan and Biocon collaboration since it is the first US regulatory submission through their joint global biosimilars program," Arun Chandavarkar, CEO and joint MD, Biocon said.

This proposed biosimilar Trastuzumab is also under review by the European Medicines Agency.

At 09:25 hours IST, the stock was quoting at Rs 1,046.25, up Rs 45.25, or 4.52 percent on the BSE.

Posted by Sunil Shankar Matkar

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