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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: The Adulthood of Biosimilars—Global Status and Future of Biosimilars
August 07, 2023
Article
Sarfaraz K. Niazi, PhD, gives an overview of the global biosimilar landscape, noting why some countries have biosimilars, including follow-on biologics and unbranded biologics, for certain products and why others do not.
BioRationality: US Senate Reignites the Push for Biosimilars to Become Interchangeable
July 24, 2023
Article
Sarfaraz K. Niazi, PhD, details his efforts to encourage congressional leaders to draft legislation that would remove interchangeability requirements and animal toxicology studies for biosimilars.
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.