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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 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.
BioRationality: EMA Announces Readiness to Waive Comparative Efficacy Studies of Biosimilars
March 04, 2024
Article
Sarfaraz K. Niazi, PhD, takes a look at the European Medicines Agency's (EMA) announcement that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.
BioRationality: Biosimilar Steaks Turn into $3 Billion Mistakes
February 19, 2024
Article
Similar to his piece on biosimilar whiskeys, Sarfaraz K. Niazi, PhD, takes on biosimilar steaks, which could be made using bioreactors to make affordable beef without harming animals, in his latest column.
BioRationality: Bringing the FDA and the USP Together to Revolutionize Biosimilars
February 05, 2024
Article
In his latest column, Sarfaraz K. Niazi, PhD, highlights challenges in biosimilar development, emphasizing the crucial role of US Pharmacopeia (USP) and advocating for collaboration and standardized guidelines to expedite cost-effective development without compromising safety or efficacy.
BioRationality: It Takes 4 to Tango—How US Entities Can Make Biosimilars Accessible
January 22, 2024
Article
The FDA, Congress, biologic developers, and associations dedicated to evaluating the US biopharmaceutical space will need to work together to overcome challenges to biosimilar accessibility, says Sarfaraz K. Niazi, PhD, in his new column.