Mylan and Biocon Submit Proposed Biosimilar Trastuzumab to FDA

Mylan and Biocon have submitted Mylan's biologics license application for drug candidate trastuzumab to the FDA through the 351(K) pathway.

Trastuzumab is indicated to treat certain HER2-positive breast and gastric cancers.

The clinical data consists of two pharmacokinetic studies and a confirmatory efficacy and safety trial that will be presented at the Nov. 15 American Society of Clinical Oncology annual meeting and the European Society for Medical Oncology (ESMO) Congress.