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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: Calling on Developers to Help Address Remaining Biosimilar Issues
October 03, 2023
Article
Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.
Part 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Forward
September 20, 2023
Article
In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.
BioRationality: First Price Reductions Under the IRA—3 Biologics With No Biosimilars
September 04, 2023
Article
Sarfaraz K. Niazi, PhD, reacts to CMS' list of the first 10 drugs chosen for price negotiation under the Inflation Reduction Act (IRA), including 3 biologics with no biosimilar competition.
BioRationality: A Calculated View on the Future of Biosimilars
August 21, 2023
Article
Sarfaraz K. Niazi, PhD, recapped his answers to a recent interview where he discussed his predictions on the future of the biosimilar industry in the United States.
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.