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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.
BioRationality: a Dr Sarfaraz Niazi Column—The EMA Declares Biosimilars Interchangeable
October 03, 2022
Article
Sarfaraz K. Niazi, PhD, explains the significance of the European Medicines Agency (EMA) declaring that biosimilars are interchangeable with their reference products and calls for the United States to do the same in the first installment of his new monthly column.
Opinion: Impact of Inflation Reduction Act 2022—Addressing Critics
August 11, 2022
Article
Sarfaraz K. Niazi, PhD, a professor, entrepreneur, and biosimilar advocate, took aim at criticisms of the Inflation Reduction Act to 2022 that was passed in the Senate and critiques the argument that the bill should be considered a “price control” measure.
Contributor: No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIA
June 27, 2022
Article
Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicles the current efforts to remove animal testing from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.
Opinion: One Step Forward, Half a Step Back for WHO Biosimilar Guidance
November 27, 2021
Article
An expert on biotherapeutics recommends more science be applied to World Health Organization (WHO) biosimilar guideline revisions.
Column: CFB Board Member Creates "Biosimilar" Whiskey
November 06, 2021
Article
Convinced that he could circumvent the time-consuming process of aging whiskey, Center for Biosimilars® Advisory Board member Sarfaraz K. Niazi, PhD, used a lab process to create "biosimilar" whiskey.
Opinion: The “Forgotten Molecules” May Reward Biosimilar Developers
October 02, 2021
Article
The Center for Biosimilars® Advisory Board member Sarfaraz K. Niazi, PhD, explains an “against the grain” approach to tapping unmet need and revenue potential in biosimilars.
Opinion: FDA Changes to Biosimilar Development Guideline Save Money and Time
September 11, 2021
Article
Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer what the author considers a more "rational approach."
Opinion: The Debate Over Animal Toxicology Studies
September 04, 2021
Article
Animal toxicology studies still get included with biosimilar approval applications, although there are strong arguments that most of these studies are unnecessary. Sarfaraz K. Niazi, PhD, explains the pros and cons.
Opinion: How to Get FDA Clinical Efficacy Testing Waivers for Biosimilars
August 28, 2021
Article
Clinical efficacy studies are not always required for biosimilars, and it's possible to resist if the FDA does ask for them. Sarfaraz K. Niazi, PhD, suggests a game plan.
Opinion: A Modified 351(a) Licensing Pathway for Biosimilars
August 21, 2021
Article
Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggests that using the 351(a) pathway for standalone drugs and copy products may be faster and better. This is part 3 of a series.