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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.
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.
Biosimilar mRNA Vaccines, Part 2: Fast-to-Market Approach!
August 07, 2021
Article
The road to production of biosimilar messenger RNA (mRNA) vaccines could be very swift compared with the experience for other biologics. With fewer intellectual property restrictions, small manufacturers could step right in, according to Sarfaraz K. Niazi, PhD.
Biosimilar mRNA Vaccines, Part 1: Regulatory Revolution!
July 31, 2021
Article
Sarfaraz K. Niazi, PhD, discusses the regulatory approval of future messenger RNA (mRNA) vaccines, which will likely face fewer patent issues and are easy to replicate.
Opinion: A Rational Approach to Establish Biosimilarity
June 05, 2021
Article
Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, reports on his citizen petition to the FDA to rationalize testing of biosimilars.
Column: A Biosimilars Dialogue With a Young Clinician
April 03, 2021
Article
Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, recounts a debate with a young clinician over the reliability of biosimilarity testing.