Mylan-Biocon's breast cancer biosimilar gets US FDA panel nod

PTI New Delhi | Updated on January 11, 2018

Drug majors Mylan and Biocon today said the US health regulator’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval for their 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.

Commenting on the development, Mylan President Rajiv Malik said: “We are pleased with ODAC’s recommendation to support the approval of Mylan’s proposed biosimilar trastuzumab to increase affordability, competition and most importantly overall access and use“.

Biocon CEO and Joint Managing Director Arun Chandavarkar said: “We now look forward to engaging with the FDA to seek final approval in order to expand access to a high—quality, affordable option for treating HER2—positive breast cancers“.

Both the companies, in a joint statement, said US Food and Drug Administration (US FDA) uses advisory committees and panels to obtain independent expert advice on a variety of matters, including product approvals.

“FDA often follows the advice of ODAC in determining whether a product should come to market, although they are not required to follow it,” they added.

Mylan and Biocon’s proposed biosimilar trastuzumab also is under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.

Shares of Biocon were trading 7.28 per cent higher at Rs 393.35 apiece on BSE.

Published on July 14, 2017

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