FDA Oncologic Drugs Advisory Committee Unanimously Recommends Approval of Mylan and Biocon’s Proposed Biosimilar Trastuzumab

Mumbai, July 18, 2017: Pharma majors, Mylan and Biocon today said the U.S food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended approval for their proposed biosimilar trastuzumab. Biocon said the committee voted 16-0 in support of eligible indications of the reference product.Herception which includes HER2-postive breast cancer in the metastatic and adjuvant setting. boicon said in a filing with BSE. Commenting on the development, Mylan President Rajiv Malik said ‘We are pleased with ODAC’s cecommendation 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 welcome ODAC’s endorsement of our biosimilar trastuzumab as it brings our collaboration a step closer to addressing the critical needs of cancer patients in the U.S. 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.’ ‘FDA often follows the advice of ODAC in determining whether a product should come to market, although they are not required to follow it,’ filing added. Mylan and Biocon’s proposed biosimilar trastuzumab also is under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.

United News of India