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’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.

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.