Sarfaraz K. Niazi, PhD, dived into the benefits of the FDA's recently announced Biosimilar Regulatory Science Program, which is expected to help progress biosimilar development and simplify evaluations for interchangeability status.
Recently, the FDA unveiled a significant effort to streamline the approval of biosimilars. For the first time, the new website highlights how the development of biosimilar products can be advanced and how the interchangeable product evaluation can be simplified and made more practical.
The FDA has made a significant shift in its priorities, as explained below:
I am looking forward to significant changes in the Biologics Price Competition and Innovation Act, but what the FDA has disclosed today should incentivize developers to present novel ideas that will reduce the cost and time to market—an essential paradigm shift needed to make biosimilars affordable. Great News!
Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical Sciences at the College of Pharmacy at the University of Illinois at Chicago and a patent law practitioner. Additionally, he is the founder and executive chairman at Pharmaceutical Scientist, Inc, the executive chairman of Karyo Biologics, and the founder of Adello Biologics, which was acquired by Kashiv Biosciences in 2019. Niazi also serves on the advisory board for The Center for Biosimilars®.
Link to Dr. Niazi’s last column: https://www.centerforbiosimilars.com/view/biorationality-a-dr-sarfaraz-niazi-column-the-ema-declares-biosimilars-interchangeable
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