Mumbai: Mylan NV and Bengaluru-based Biocon Ltd said on Friday that the US Food and Drug Administration’s (FDA) oncology drugs advisory committee had recommended approval of their biosimilar trastuzumab, indicated for treatment of breast cancer. Mylan and Biocon’s proposed biosimilar trastuzumab is also under review by regulatory authorities in Australia, Canada, Europe and several emerging markets. Until the drug product facility gets clearance, Biocon will not get marketing approval for its biosimilars in the European market. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by the companies. Mylan has exclusive commercialization rights for biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.

Source: Mint July 14, 2017 06:33 UTC