Accelerating access to high quality biologics
Over the past two decades, the biotechnology industry has developed a spectrum of biologic drugs, changing the way the world looks at medicine. Many of these expensive biologics have successfully altered standard of care for several difficult-to-treat conditions including cancer. The increased acceptance of biologic drugs as mainstay therapies has also led to the need for more-affordable versions called “biosimilars.” The World Health Organization defines a biosimilar products as similar to biologics in terms of quality, safety and efficacy to an already-licensed reference bio-therapeutic product.
Central to our approach to establishing biosimilarity is a drug characterization strategy that compares the biosimilar with the reference product on analytical, functional and quality measures. This detailed comparison forms the basis for reduced data requirements at the non-clinical and clinical level. It also lets us develop robust processes, eliminating differences that may potentially have a functional impact. This strategy sequentially reduces uncertainty of potential differences in efficacy, safety and outcome when used in patients.
Our R&D capability in Biologics is exemplified by a number of firsts in the biosimilar field. Dr. Reddy’s launched the first biosimilar filgrastim (G-CSF) in India, followed by the first biosimilar MAb (Rituximab) in the world in 2007, the first biosimilar darbepoetin alfa in the world in 2010 and first & only single source peg-filgrastim in 2011. We also have filed 2 Active Investigational drug application (INDs) with the US FDA.
We are able to achieve these firsts because of our end-to-end capabilities and an integrated research organization connecting Hyderabad, Princeton and Basel. This integrated organization gives us significant competitive advantage in product and clinical development, global regulatory affairs, manufacturing and commercialization.