Mylan-Biocon’s breast cancer biosimilar gets US FDA nod

Drug majors Mylan and Biocon 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, Rajiv Malik, President, Mylan 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."

Arun Chandavarkar, CEO and Joint MD, Biocon 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.