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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: 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.
BioRationality: An Analysis of the Future of Biosimilars Through the Eyes of History
January 08, 2024
Article
Sarafraz K. Niazi, PhD, previews the new year and his hopes for the end of clinical efficacy testing for biosimilar approvals using examples from history of other scientific concepts that took time to gain traction.
BioRationality: In FDA We Trust—A Commentary on FDA Efforts to Educate Biosimilar Stakeholders
December 18, 2023
Article
Sarfaraz K. Niazi, PhD, offers his perspective on FDA biosimilar education efforts and the role these efforts and stakeholder perspectives play in uplifting—or undermining—biosimilar adoption.
BioRationality: Efficacy Testing and Interchangeability of Biosimilar Remains a Dogma for Most
December 04, 2023
Article
Sarfaraz K. Niazi, PhD, comments on a poll he conducted revealing that many are still hesitant to remove clinical efficacy study requirements for biosimilars in his latest column.
BioRationality: FDA Publishes Results of First Meta-Analysis to Conclude All Biosimilars Are Interchangeable
November 20, 2023
Article
Sarfaraz K. Niazi, PhD, offers hope for the end of interchangeability labels in the United States in his latest column.
BioRationality: FDA Launches a New Opportunity to Remove Redundant Trials of Biosimilars
November 06, 2023
Article
The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.
BioRationality—A DMF Route to Biosimilars: CDMOs Can Make Biosimilars Accessible and Affordable
October 16, 2023
Article
Sarfaraz K. Niazi, PhD, chronicles how drug master files (DMF) can be used in the biosimilar approval process and the role contract development and manufacturing organizations (CDMOs) can play in improving biosimilar accessibility.