Biocon’s Breast Cancer Biosimilar Gets USFDA Panel Nod, Shares Surge
The older Mylan and Biocon drugs, said today that the Advisory Committee on Cancer Medicines (ODAC) of the United States Health Authority approval of trastuzumab biosimilar proposal recommended, indicated for the treatment of breast cancer.
In a filing with regulators, Biocon said the committee had voted 16-0 in support of eligible indications of the reference product.
“This vote is the first biosimilar trastuzumab proposal recommended by the committee,” he added.
Regarding development, Mylan President Rajiv Malik said: “We are delighted with ODAC’s recommendation to support the approval of Mylan’s biosimilar trastuzumab to increase affordability, competition and, above all, global access and use” .
CEO and CEO of Biocon joint Arun Chandavarkar, said: “We look forward to working with the FDA to obtain final approval to expand access to the affordable and high-quality treatment option for HER2 positive breast cancer.”
The two companies, in a joint statement, said the US Food and Drug Administration uses committees and charts to obtain advice from independent experts on various topics including product approval.
“The FDA generally follows the advice of ODAC to determine if a product should come on the market, even though they are not required to continue,” they added.
The biosimilar trastuzumab proposed by Mylan and Biocon is also under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.
Biocon shares rose 8.19% compared to Rs. 396,70 each on BSE.