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Biocon shares rally on USFDA panel nod for breast cancer biosimilar

Biocon, Financial Results

Mumbai: Shares of Biocon surged as the US health regulator’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval for the company's proposed biosimilar Trastuzumab, indicated for breast cancer treatment.

In a regulatory filing, Biocon said the committee voted 16-0 in support of eligible indications of the reference product. “This vote marks first proposed biosimilar Trastuzumab to be recommended by the committee,” it added.

Shares of Biocon Ltd were up as much as 10 per cent at Rs. 404.45 - highest since June 2002.

At 11.45 a.m., the shares were trading higher by 8.06 per cent at Rs. 396.20 on the BSE. On the NSE, the stock was up 7.81 per cent at Rs. 396.40.

US FDA's Oncologic Drugs Advisory Committee of experts has unanimously recommended approval for breast cancer treatment Trastuzumab, developed by Mylan NV and Biocon.

The FDA's final decision is pending, but the agency typically favours the panel's recommendation, although it is not required to do so.

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products.

Up to Thursday's close, Biocon's shares had risen 16 per cent this year.


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