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.

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.

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.