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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.
Biosimilar mRNA Vaccines, Part 2: Fast-to-Market Approach!
August 07, 2021
Article
The 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.
Biosimilar mRNA Vaccines, Part 1: Regulatory Revolution!
July 31, 2021
Article
Sarfaraz K. Niazi, PhD, discusses the regulatory approval of future messenger RNA (mRNA) vaccines, which will likely face fewer patent issues and are easy to replicate.
Opinion: A Rational Approach to Establish Biosimilarity
June 05, 2021
Article
Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, reports on his citizen petition to the FDA to rationalize testing of biosimilars.
Column: A Biosimilars Dialogue With a Young Clinician
April 03, 2021
Article
Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, recounts a debate with a young clinician over the reliability of biosimilarity testing.
Opinion: A Short History of Biosimilars
February 27, 2021
Article
Biosimilars have come a long way, and their path has mirrored that of generics—fraught with obstacles. Still, a stronger embrace is needed from physicians and payers.
Opinion: Boehringer Ingelheim May Win Regulatory Language Change Despite Weak Argument
December 12, 2020
Article
Boehringer Ingelheim's argument hinges on how "strength" of formulation is defined in regulatory language.
Ten Reasons Why Biosimilar Candidates Should Not Be Tested for Clinical Efficacy
October 31, 2020
Article
The FDA may require comparative clinical efficacy for biosimilar approval, but on top of all the other required and available evidence, these trials add little value, Sarfaraz K. Niazi, PhD, states.
Biosimilarity: A Novel Approach to Develop Therapies and Vaccines for COVID-19
September 05, 2020
Article
Biological Drugs in the Aftermath of the Pandemic
July 18, 2020
Article
Although devastating in its toll on human life, the coronavirus disease 2019 will likely bring new understanding and technology and leave us better prepared to manage the next health threat of this scope.
Analysis of FDA-Licensed Biosimilars: Time for a Paradigm Shift
July 11, 2020
Article
Now 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.