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: FDA Calls Meeting to Reevaluate the Need for Clinical Efficacy Testing of Biosimilars

July 10, 2023

Article

Sarfaraz K. Niazi, PhD, flagged an upcoming FDA meeting where stakeholders can make public comment on whether clinical efficacy testing for biosimilars is necessary for regulatory approval.

BioRationality: Biosimilars Are Not Doing Well—Time for a Change in Perspective

June 26, 2023

Article

In his latest column, Sarfaraz K. Niazi, PhD, takes a look at common misconceptions about biosimilar development and expresses how companies can seize new opportunities to save the US biosimilar market and generate profit.

BioRationality: New FDA Guideline Invites Biosimilar Developers to Reduce the Cost of Testing

June 12, 2023

Article

Sarfaraz K. Niazi, PhD, examined the new FDA guideline that acts as an invitation to biosimilar developers to decrease the cost of testing, potentially opening the door for companies to reduce nonclinical testing of biosimilars entirely.

BioRationality: The Do’s and Don’ts of Adding Novelty to Biosimilars Development

May 30, 2023

Article

In his latest column, Sarfaraz K. Niazi, PhD, went over some best practices for implementing innovative solutions for the purposes of streamlining biosimilar development.

Biorationality: Advice for the FDA, Biosimilar Developers on Reducing the Cost of Clinical Testing

May 15, 2023

Article

Although the FDA has consistently edited its testing guidelines for biosimilar developers over the years, clinical testing is still very expensive and time-consuming. Sarfaraz K. Niazi, PhD, offers the FDA and companies a plan of action for reducing clinical testing expenses for biosimilar products.

BioRationality: FDA Advice to Biosimilar Developers on Using PD Markers, Avoid Clinical Efficacy Testing

May 01, 2023

Article

Sarfaraz K. Niazi, PhD, dives into how pharmacodynamic (PD) markers may be better than clinical efficacy testing for predicting whether a biosimilar is equally as safe and effective as its reference product, in his latest column.

BioRationality: FDA Final Guidance on Continuous Manufacturing—A Boon for Biosimilars

April 17, 2023

Article

The misconceptions about disposable bioreactors' lifecycle are gone; the era of hard-piped, giant, stainless-steel tanks for biosimilar development is history now, according to Sarfaraz K. Niazi, PhD, in his latest column.

BioRationality: FDA Changes the BsUFA Meetings Scope—How to Expedite the Regulatory Approval of Biosimilars

April 03, 2023

Article

Sarfaraz K. Niazi, PhD, explains and analyzes the FDA's changes for the Biosimilar User Fee Act (BsUFA) meetings and how they influence the efficiency of the biosimilar approval process in the latest installment of his bimonthly column.

Contributor: FDA Introduces New AI-Based Safety Evaluation Tool to Help Demonstrate Biosimilarity

March 14, 2023

Article

The FDA's new artificial intelligence (AI)-based modeling on characterizing protein aggregation could directly impact the safety assurance of biosimilars and other therapeutic proteins.

Biorationality: A Dr Sarfaraz Niazi Column—A New Perspective on Biosimilars' Role Within Big Pharma

March 13, 2023

Article

Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.