The US Food and Drug Administration (USFDA) Oncologic Drugs Advisory Committee (ODAC) has unanimously recommended approval of Mylan and Biocon's Proposed Biosimilar Trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin, which include HER2-positive breast cancer in the metastatic and adjuvant settings.
Mylan and Biocon's proposed biosimilar trastuzumab is also under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace.