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—FDA Discloses Changes to Drug Review Process, Biosimilar Licensing

January 30, 2023

Article

Sarfaraz K. Niazi, PhD, explains the FDA's changes to the drug review process, the significance of each change, and the published pieces of work that helped inform the FDA's decisions.

BioRationality: A Dr Sarfaraz Niazi Column—Biosimilar Gene Therapy to Resolve the Most Critical Affordability Issue

January 16, 2023

Article

In his column, Sarfaraz K. Niazi, PhD, chronicles the potential for biosimilars referencing some of the biggest cell and gene therapies as well as why companies should begin looking into biosimilar development efforts in this space.

BioRationality—A Dr. Sarfaraz Niazi Column: Lessons From 2022 Biosimilar Events

January 04, 2023

Article

Sarfaraz K. Niazi, PhD, summarizes some of the lessons that the entire biosimilar industry can take away from 2022, including what new legislation and policy changes could mean for future biosimilar development.

BioRationality: A Dr Sarfaraz Niazi Column—The Unmined Treasure of Ignored Biosimilars

December 20, 2022

Article

Sarfaraz K. Niazi, PhD, breaks down the current status of biosimilar development and makes suggestions for which molecules manufacturers should target next in his newest column installment.

BioRationality: A Dr Sarfaraz Niazi Column—US Senate Considers Nixing Interchangeability for Biosimilars

December 13, 2022

Article

In his newest column, Sarfaraz K. Niazi, PhD, looks into the domestic and international support for removing interchangeability for biosimilars in the United States.

BioRationality: A Dr Sarfaraz Niazi Column—FDA Launches Biosimilar Regulatory Science Program

November 07, 2022

Article

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.

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.