Biocon, Mylan submit biosimilar license application to USFDA

Bengaluru-based Biocon and its partner Mylan Inc today announced submission of Mylan's biologics licence application to USFDA for a proposed biosimilar to branded trastuzumab for treatment of certain breast and gastric cancers.
The companies said they believed that the product, MYL-1401O, has the potential to be the first submission of a proposed biosimilar trastuzumab in the US.
Commenting on the development, Mylan President Rajiv Malik said: "This submission also is another demonstration of the strength of the Mylan/Biocon partnership and our shared commitment to increasing access to these critical medicines worldwide."
He further said: "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."

Biocon CEO & Joint MD Arun Chandavarkar termed the submission as "an important milestone of Biocon and Mylan's joint global biosimilars program"
It "demonstrates our commitment to provide access to high-quality and affordable biologics to patients across the globe. Cancer patients in India and emerging markets have benefited with our trastuzumab and this advancement in the US will enable us to enhance access to this affordable therapy to larger patient pools," he added.