Personal life
Niazi was born on 10 July 1949 inEducation
Niazi earned a Bachelor of Science degree inEmployment
From 1972 to 1988, he taught at the College of Pharmacy at the University of Illinois at Chicago, and continues to serve as Adjunct Professor of Biopharmaceutical Sciences. From 1988 to 1996, he worked forHonorary teaching
Since 2012, he has served as an adjunct professor at the College of Pharmacy, University of Illinois, and since 2004 he has served as anPoetry
In 2002, Niazi published the first complete translation of theResearch
Niazi has published over 100 research articles, and is the creator of a variable volume distribution model to study the safety and efficacy of drugs.Biosimilars
Niazi has shared his knowledge in several publications in the field of biosimilars. He has published multiple books on the subject and peer-reviewed research papers that advise developers on how to secure a faster approval of biosimilars by the FDA and EMA and suggest changes to harmonize approval guidelines. He has also introduced the concept of biosimilar mRNA vaccines. He has also created biosimilar whiskies Forbes magazine has for the third time recognized and reported his work on biosimilars, recently on his lifetime contributions.; he was also listed as the Most Interesting Man Revolutionizing Healthcare by the Forbes Magazine also. Forbes also recognized his work on advising the FDA on making changes to regulations.Politics
Niazi has recently challenged the Biosimilars Council, disreputing the Congressional Bill intended to reduce the cost of drugs to Medicare patients as a price control measure that will hurt the industry. In a line-by-line analysis in a peer-reviewed journal, Niazi stated that these oppositions are merely political as all Republicans opposed the Bill.Niazi SK. End animal testing for biosimilar approval. Science. 2022 Jul 8;377(6602):162-163. doi: 10.1126/science.add4664. Epub 2022 Jul 7. PMID 35857557.FDA/WHO
Niazi has challenged FDA guidance through three Citizen Petitions that urge the FDA to rationalize testing to allow faster entry of generic drugs and biosimilars to the market. In response to Niazi's Citizen Petition, the FDA withdrew pivotal guidance for approving biosimilars. Niazi has also challenged the World Health Organization's guidance on approving biosimilars as weak on science leading to the possibility of the use of unsafe biological drugs in developing countries. He has suggested harmonizing the guidelines for approval of biosimilars removing the animal and phase 3 studies that will significantly reduce the cost of biosimilars. Niazi also contributed to Senate Bill introduced by Senator Lee recognizing his recommendations to remove the interchangeability status of biosimilars. The FDA has awarded a grant of $2 million to Niazi working with Professor Anna Schwendeman to develop new analytical technologies to reduce the testing of biosimilars and remove clinical efficacy testing. A citizen petition filed by Niazi in September 2023 demands that the FDA modify its biosimilars approval based on new scientific findings and offers a critical analysis of the suggestions by the FDA to use Omics technology to create pharmacodynamic markers for monoclonal antibodies, an exercise that Niazi considers impractical and unnecessary and instead offers alternatives that are readily adoptable.Animal rights
Niazi has strongly opposed animal testing of biosimilars in the prestigious Science magazine; he has also referred to the new FDA perspective that even new biological drugs need not be tested in animals, all because animals do not have the receptors for the biological drugs to bind and thus show pharmacology or toxicology. Niazi assisted US Senate in the drafting of the FDA Modernization Act 2.0, convincing the Senators to remove animal testing of generic and biological drugs; it became law in 2023Inventions
Niazi owns 177 patents in the field of bioprocessing, digital technology, new drugs, new dosage forms, and herbal medicines. Niazi is also a patent law practitioner.Awards
On 14 August 2012, theTextbooks and professional handbooks
Niazi has published dozens of books; His textbooks are generally made available royalty-free in the developing world. * ''Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues.'' Boca Raton, Florida: CRC, 2002. . * ''Textbook of Clinical Pharmacokinetics and Biopharmaceutics.'' Bsp, India. 2010. . * ''Handbook of Bioequivalence Testing.'' Boca Raton, Florida: CRC, 2014. . * ''Biosimilar and Interchangeable Biologics: From Cell Line to Commercial Launch, Two Volume Set 1st Edition.'' Boca Raton, Florida: CRC, CRC, 2015. . * ''Fundamentals of Bioprocess Engineering.'' Boca Raton, Florida: CRC, FL. 2015 * ''Love Sonnets of Ghalib.'' Rupa Publications, New Delhi, India, 2017. . * ''Biosimilarlity—The FDA Perspective.'' Boca Raton, Florida: CRC, 2018. . * ''Handbook of Pharmaceutical Manufacturing Formulations Volumes 1–6.'' Boca Raton, Florida: CRC, 2019. . * ''Handbook of Preformulation: Drugs, Botanicals, and Biological Pharmaceutical Products. Second edition.'' Boca Raton, Florida: CRC, 2019. . * ''Future of Pharmaceuticals. A Nonlinear Analysis.'' Boca Raton, Florida: CRC, 2022. . * ''mRNA Therapeutics--A Fast to Market Strategy''. CRC Press, Boca Raton, Florida. * ''Biopharmaceutical Manufacturing, Volume 1 Regulatory processes. Professor Sarfaraz K. Niazi, Sunitha Lokesh.'' Bristol, UK 2021. . * ''Biopharmaceutical Manufacturing, Volume 2 Unit Operations. Professor Sarfaraz K. Niazi, Sunitha Lokesh.'' Bristol, UK 2021. . * ''Wine of Love, Persian Ghazals of Ghalib, Translations, and Explications'' by Sarfaraz Niazi and Maryam Tawoosi Ghalib Academy of America .References
External links
* {{DEFAULTSORT:Niazi, Sarfaraz K. Pakistani translators Pakistani writers Academics from Karachi 1949 births Living people Recipients of Sitara-i-Imtiaz Indian emigrants to Pakistan Pakistani emigrants to the United States American businesspeople University of Karachi alumni Academic staff of Aga Khan University Academic staff of the National University of Sciences & Technology Pakistani pharmacists People from Lucknow Scientists from Chicago