Mylan and Biocon submit biologics license application to USFDA
Global generic pharmaceutical company Mylan and Indian biotechnology firm, Biocon have given a submission of Biologics Licence Application (BLA) for proposed biosimilar, trastuzumab to the US Food and Drug Administration (FDA).
November 8, 2016: The product MYL-1401O has been proposed for the branded trastuzumab used for treating certain HER2-positive breast and gastric cancers.
The BLA provides data on analytical similarity, nonclinical, clinical data consisting of two pharmacokinetic studies along with confirmatory efficacy and safety trial. The proposed biosimilar is one among the six biologic products developed co jointly by Mylan and Biocon for the global market.
The approval from USFDA will help greater access of the medicine to large patient pools in the developed market. Cancer patients in India and emerging markets have already benefitted from the biosimilar.