born 10 July 1949) is a Pakistani-American academic and entrepreneur working in pharmaceutical sciences and biopharmaceutical manufacturing. He has written books in pharmaceutical sciences, biotechnology, consumer healthcare, and poetry. He has translated ghazals (love poems) of the Urdu poet Ghalib.
Personal life Niazi was born on 10 July 1949 in Lucknow in India, and moved to Karachi with his parents in 1962.Express News, Pakistan. 2 Oct 2014 ڈاکٹر سرفراز خان نیازی ؛ دنیائے طب میں انقلاب لانے والے پاکستانی سائنس دان English version via Google translate His father was Niaz Fatehpuri, a scholar of religion and literature in Pakistan and India.Sarfaraz K. Niazi. Love Sonnets of Ghalib. Rupa & Co. (10 January 2009) , see back flap.
Education Niazi earned a Bachelor of Science degree in pharmacy from the University of Karachi in 1969. In 1970, he moved to the United States, where he obtained his Master of Science degree in pharmaceutical sciences in 1971 from Washington State University in Pullman, WA, and then moved to Illinois. In 1974, he obtained his doctorate in pharmaceutical sciences from the University of Illinois at Chicago. Washington State University lists him as a 1971 alumnus and an affiliate faculty member of its Department of Pharmaceutical Sciences.
Employment Niazi was an associate professor at the College of Pharmacy of the University of Illinois at Chicago and later an executive at Abbott Laboratories. In 1997, he established a consulting business, Pharmaceutical Scientist, Inc. In 2003, he launched Therapeutic Proteins International LLC with about US$1 million from friends and other investors; by 2014 the company was developing a biosimilar of Amgen's filgrastim (Neupogen).
Academic appointments Niazi joined the University of Illinois at Chicago (UIC) College of Pharmacy as an instructor in 1972. Washington State University (WSU) states that he became UIC's youngest tenured professor at age 27. He is an adjunct professor of biopharmaceutical sciences at UIC and the University of Houston. WSU says he plans to help establish a biosimilar analytical testing centre at the college, and lists a period at the United Nations' International Centre for Genetic Engineering and Biotechnology in Italy among his earlier positions.
Niazi reports having supervised 46 master's and doctoral students. In 1977 he was a co-investigator on a National Institutes of Health grant to develop a self-paced degree-teaching program at the University of Illinois.
Business ventures A publisher's author biography says Therapeutic Proteins International was later renamed Adello Biologics, and The Center for Biosimilars describes Niazi as Adello's founder and as executive chairman of Karyo Biologics. Adello submitted a biologics licence application for its filgrastim biosimilar in 2017 and was a party to patent litigation with Amgen under the Biologics Price Competition and Innovation Act (BPCIA). In January 2019 Kashiv Pharma acquired Adello's assets and became Kashiv BioSciences. In 2022 the FDA approved Fylnetra (pegfilgrastim-pbbk), developed by Kashiv with Amneal Pharmaceuticals; Adello had worked on its brand name. WSU states that Niazi has raised more than US$500 million in investment capital over his career.
Since 2023 he has been chief executive of RNA Therapeutics, Inc., based in Deerfield, Illinois, which works on mRNA and gene-therapy products.
Advisory and policy work Niazi has advised regulators and governments on biosimilar and generic-drug policy, including in Uzbekistan, Turkey, Pakistan, Canada, Japan and Saudi Arabia. Since 2012 he has advised the Higher Education Commission of Pakistan on intellectual-property management. He has served as teaching faculty and adviser to the United States Pharmacopeia and as an expert witness in pharmaceutical patent cases. Between 2008 and 2016 he hosted a radio programme for the Voice of America. He is a member of the advisory board of The Center for Biosimilars, where he writes the "BioRationality" column.
In May 2022 Senator Ben Ray Luján introduced S. 4288, the Reducing Animal Testing Act, which would remove animal studies as a required part of biosimilar applications under the BPCIA. Niazi has written that he developed the amendment together with Luján's office; the senator's own press release does not name him. The same biosimilar provision appears in the FDA Modernization Act 2.0 (S. 5002), which passed the Senate on 29 September 2022. Niazi also published a letter in Science that year arguing for an end to animal testing in biosimilar approval.
Inventions and patents Niazi has been a registered patent agent before the United States Patent and Trademark Office since 2002 and wrote Filing Patents Online: A Professional Guide (CRC Press, 2003). He is named as inventor on patents and patent applications in areas including biologics manufacturing, analytical comparison of biomolecules, drug delivery and pharmaceutical compositions. Examples listed in patent databases include a "Purification and Separation Treatment Assembly (PASTA) for Biological Products" (CN104169426A), "Comparing the Structures of Two Biomolecules" (EP3030263A1) and a "Thermodynamic Equivalence Surrogate Test (TEST) for Bioequivalence" (EP3096744A1).
Poetry In 2002, Niazi published the first complete translation of the ghazals of Mirza Asadullah Baig Khan, known as "Ghalib"Gulzar for India Today. 25 February 2002 Ghalib in love. Book review: Love Sonnets of Ghalib, translated by Sarfaraz K. Niazi and another in 2009.Jamaluddin Aali, quoted in Sarfaraz K. Niazi. Wine of Passion. Lahore, Pakistan: Ferozsons Publishing, 2009 The translation was reviewed in The Tribune, whose reviewer praised the explications that accompany the translated ghazals. In 2023, Niazi published the first complete English translation of Ghalib's Persian love poems with Mariam Tawoosi
Translations of Persian poetry Niazi and Maryam Tawoosi also published There Is No Wisdom: Selected Love Poems of Bedil (Ferozsons, Lahore, 2015), an English rendering of verse by the Persian-language poet Abdul-Qadir Bedil.
Biosimilars Niazi's primary research subject is 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. In May 2018, Niazi filed a Citizen Petition with the FDA proposing changes to the biosimilar approval process, including allowing a non-US-licensed comparator product without bridging studies.
Awards On 14 August 2012, the Government of Pakistan announced that President Asif Ali Zardari would be awarding the in Engineering Science to Sarfaraz.
Other honours and recognition Fellow of the Royal Society of Biology, the Pakistan Academy of Medical Sciences and the American Society of Clinical Biochemistry; member of the Abbott Volwiler Society. Inducted into the Chicago Area Entrepreneurship Hall of Fame (UIC Institute for Entrepreneurial Studies), gala on 8 October 2015, listed as representing Therapeutic Proteins International, LLC. Alumni of the Year, University of Illinois. Innovation of the Year, Global Generics & Biosimilars Awards, 2014. Finalist, Best Upstream Technology Application, BioProcess International awards, 2012, for single-use production of bacterial proteins. Profiled in Forbes in 2014; further Forbes contributor pieces followed in 2018, 2019 and 2023.
Textbooks and professional handbooks
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. New Delhi: Rupa Publications, 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 .
Additional books Before his biopharmaceutical titles, Niazi published popular health books through Esquire Press (Illinois), including The Omega Connection (1982), Adsorption and Chelation Therapy (1987), Attacking the Sacred Cows: The Health Hazards of Milk (1988) and Endorphins: The Body Opium (1988). Wellness Guide (Ferozsons, Lahore, 2002) is an illustrated health book. Later titles not listed above include Filing Patents Online (CRC Press, 2003), Disposable Bioprocessing Systems (CRC Press, 2012), There Is No Wisdom (2015), Handbook of Biological Therapeutic Proteins, 2nd ed. (CRC Press, 2024), Fast-to-Market Biosimilars (CRC Press, 2025) and Cell Free Synthesis of Biologics (Elsevier).
Selected recent publications
References
External links