'The US FDA Approval Of Trastuzumab Is A Huge Milestone For Biocon'

First biosimilar Trastuzumab has been recently approved by the US FDA. Kiran Mazumdar Shaw, CMD, Biocon, reveals more an in an interaction with Express Pharma

The US FDA approval for biosimilar Trastuzumab comes at a time when the global biosimilars opportunity is just beginning to open up. What does this approval mean for the Indian pharma industry in general and Biocon in particular?

The US FDA approval of Trastuzumab is a huge milestone for Biocon as well as the Indian biotech sector since this is the first biosimilar from India to be approved in the US. More importantly it is also the first biosimilar Trastuzumab to be approved by the US FDA. This approval is a validation of our development, regulatory and manufacturing capabilities in the complex area of biosimilar versions of monoclonal antibodies, which require advanced scientific capabilities and stringent quality controls.

This approval has established Biocon as a credible biologics player from India and has put us in an exclusive league of global biosimilar players.

It has also strengthened our resolve to focus on developing affordable biologics that can make cancer care both, more effective and more equitable around the world. It will spur us on our journey of developing advanced therapies that have the potential to benefit billions of patients.