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A Critical Analysis of the Final Guidance on Demonstrating Interchangeability of a Biosimilar With Its Reference Product Sarfaraz K. Niazi, PhD Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded…

The FDA has now agreed with my suggestion to remove the requirements of clinical testing where it does not definitively add any value. Sarfaraz K. Niazi, PhD Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics…

Sarfaraz K. Niazi, PhD Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci. December 07, 2018 The Biologics Price Competition and Innovation Act of 2009…

Commentary on Dr. Niazi publication

The slow entrance and acceptance of biosimilars in the US is the result of high costs and long development times – nearly US$250 million and almost eight years [7] – as well as a gross misunderstanding of the safety of biosimilars among prescribers and the public, principally due to ideas put forward by the products’…

 This review focuses on actions FDA, biosimilar developers and other stakeholders can take, within the boundaries of the statute, to make biosimilars more accessible. In order to first understand what is feasible for FDA and how the relevant guidelines are constructed, a review of the BPCI Act is necessary   Generics and Biosimilars Initiative Journal (GaBI…