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 Opens Up Biosimilar Inquiries on Reddit

August 26, 2024

Article

Sarfaraz K. Niazi, PhD, urges stakeholders to engage with the FDA on its Reddit forum—where a representative will answer complex biosimilar questions—encourages clearing misconceptions, and advocates for updates to the Biologics Price Competition and Innovation Act guidelines.

BioRationality: Bill to Remove Double Patenting That Harms Biosimilars Heads to the House

August 12, 2024

Article

Sarfaraz K. Niazi, PhD, argues that the S-150 bill, also known as the "Affordable Prescriptions for Patients Act of 2023," aims to reduce drug prices by addressing anti-competitive practices, such as patent thickets and product hopping, which hinder the entry of cheaper biosimilars and generics into the market.

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.