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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: FDA Simplifies Glycan Profiling of mAbs, a Significant Step in Reducing the Cost of Biosimilars
July 29, 2024
Article
The FDA's new policy on glycan profiling of monoclonal antibodies (Mabs) receives praise and recommendations from Sarfaraz K. Niazi, PhD.
BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed
July 15, 2024
Article
Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.
BioRationality: FDA Removes Additional Testing for Interchangeable Status of Biosimilars
July 01, 2024
Article
Sarfaraz K. Niazi, PhD, champions the FDA's updated guidance to remove switching study data for companies seeking to obtain an interchangeability designation for their biosimilars.
BioRationality—How to Promote Science to Secure Waiver of Comparative Efficacy Testing for Biosimilars
June 17, 2024
Article
Sarfaraz K. Niazi, PhD, makes suggestions for what arguments will help convince the FDA to waive clinical efficacy testing requirements for biosimilar approvals.
BioRationality: FDA Updates Its Biosimilars Action Plan—A Major Step in Bringing More Biosimilars to Patients
June 03, 2024
Article
Sarfaraz K. Niazi, PhD, analyzes updates to the FDA's Biosimilars Action Plan, as well as the agency's increased efforts to boost biosimilar adoption and education.
BioRationality: FDA Pridefully Declares 50th Biosimilar Approval
May 20, 2024
Article
Sarfaraz K. Niazi, PhD, congratulates the FDA on approving the 50th biosimilar, noting that there's more work to be done to expand the market.
BioRationality—FDA’s Guidance on Promotional Labeling
May 06, 2024
Article
Sarfaraz K. Niazi, PhD, explains FDA's new guidance on promotional labeling as well as challenges and insights into how this new guidance will impact biosimilars.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15, 2024
Article
Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
BioRationality: President Biden’s 2025 Budget and Removing Biosimilar Interchangeability
April 01, 2024
Article
Sarfaraz K. Niazi, PhD, outlines how President Joe Biden's new budget for 2025 could impact biosimilars, including provisions to clear up confusion surrounding interchangeable products.
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18, 2024
Article
Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.