Global pharma major Mylan and Biocon have announced submission of Mylan’s biologics license application for MYL-1401O, a proposed biosimilar trastuzumab, to the US Food and Drug Administration (FDA). This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and Biocon believe that this has the potential to be the first submission of a proposed biosimilar trastuzumab in the US. The submitted BLA includes a comprehensive package of analytical similarity, nonclinical and clinical data. The clinical data consists of two pharmacokinetic studies and the heritage study for confirming efficacy and safety aspects. The results of the heritage trial were presented at this year’s American Society of Clinical Oncology (ASCO) annual meeting and the European Society for Medical Oncology (ESMO) Congress.
“The FDA submission for biosimilar trastuzumab marks Mylan’s first FDA biosimilar submission from our broad portfolio of biosimilar products in development and our product has the opportunity to be the first biosimilar trastuzumab approved in the US,’’ Mylan president Rajiv Malik said in a statement.
“This submission is another demonstration of the strength of the Mylan and Biocon partnership and our shared commitment to increasing access to these critical medicines worldwide. Our trastuzumab biosimilar is already being sold in 11 developing markets, including India, and we look forward to bringing the product to market in the US and Europe upon approval,” he added.