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: A Dr Sarfaraz Niazi Column—A New Perspective on Biosimilars' Role Within Big Pharma
March 13th 2023Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.
BioRationality: A Dr Sarfaraz Niazi Column—Avoid Delays in Biosimilar Approvals Due to CRLs
February 27th 2023Although a complete response letter (CRL) is not an official rejection letter, it can result in approval delays by listing out shortcomings in an application and giving companies an opportunity to respond. In his latest column, Sarfaraz K. Niazi, PhD, goes over how companies can avoid these approval postponements.
BioRationality: A Dr Sarfaraz Niazi Column—Misconceptions in the Adoption of Biosimilars
February 13th 2023Sarfaraz K. Niazi, PhD, goes over some misconceptions surrounding biosimilar adoption as well as some national efforts to make biosimilar uptake easier and biosimilar development more economically efficient.
BioRationality—A Dr. Sarfaraz Niazi Column: Lessons From 2022 Biosimilar Events
January 4th 2023Sarfaraz K. Niazi, PhD, summarizes some of the lessons that the entire biosimilar industry can take away from 2022, including what new legislation and policy changes could mean for future biosimilar development.
BioRationality: A Dr Sarfaraz Niazi Column—FDA Launches Biosimilar Regulatory Science Program
November 7th 2022Sarfaraz K. Niazi, PhD, dived into the benefits of the FDA's recently announced Biosimilar Regulatory Science Program, which is expected to help progress biosimilar development and simplify evaluations for interchangeability status.
BioRationality: a Dr Sarfaraz Niazi Column—The EMA Declares Biosimilars Interchangeable
October 3rd 2022Sarfaraz K. Niazi, PhD, explains the significance of the European Medicines Agency (EMA) declaring that biosimilars are interchangeable with their reference products and calls for the United States to do the same in the first installment of his new monthly column.
Opinion: Impact of Inflation Reduction Act 2022—Addressing Critics
August 11th 2022Sarfaraz K. Niazi, PhD, a professor, entrepreneur, and biosimilar advocate, took aim at criticisms of the Inflation Reduction Act to 2022 that was passed in the Senate and critiques the argument that the bill should be considered a “price control” measure.
Contributor: No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIA
June 27th 2022Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicles the current efforts to remove animal testing from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.
Opinion: A Modified 351(a) Licensing Pathway for Biosimilars
August 21st 2021Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggests that using the 351(a) pathway for standalone drugs and copy products may be faster and better. This is part 3 of a series.
Biosimilar mRNA Vaccines, Part 2: Fast-to-Market Approach!
August 7th 2021The road to production of biosimilar messenger RNA (mRNA) vaccines could be very swift compared with the experience for other biologics. With fewer intellectual property restrictions, small manufacturers could step right in, according to Sarfaraz K. Niazi, PhD.
Analysis of FDA-Licensed Biosimilars: Time for a Paradigm Shift
July 11th 2020Now is the time for the FDA to lead again in revising the biosimilar development guidance by eliminating all animal toxicology studies, and replacing them with larger-species pharmacokinetic (PK) studies, allowing the conduct of human PK studies using novel clinical protocols to combine the PK/pharmacodynamic/immunogenicity testing in a single study, and, where possible, avoid these studies if an in-silico approach can provide the confidence of pharmacologic similarity.