Biocon Says U.S. FDA Advisory Committee Favours Nod For Proposed Biosimilar
Shares of Biocon Ltd. rose as much as 10 percent to Rs 404.45, a new all-time high for the stock, after a breast cancer drug developed by the Bengaluru-based firm and U.S.'s Mylan received a favourable approval from the U.S. drug regulator's advisory committee.
The U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of the proposed biosimilar Trastuzumab, Biocon said in an exchange filing. The committee voted 16-0 in support of eligible indications of reference product Herceptin.
The drug regulator uses advisory committees and panels to obtain independent expert advice on a variety of matters, including product approvals. The FDA often follows the advice of ODAC in determining whether a product should come to market, although they are not required to follow it.
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.”Arun Chandavarkar, CEO And Joint Managing Director, Biocon
The proposed biosimilar Trastuzumab is one of the six biologic products co-developed by Mylan and Biocon. The drug is also under review by regulatory authorities in Australia, Canada, Europe and several emerging markets, the company said.
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