Sarfaraz K. Niazi

Niazi was born on 10 July 1949 in Lucknow in India, and moved to Karachi with his parents in 1962.^[2] His father was Niaz Fatehpuri, a scholar of religion and literature in Pakistan and India.^[3]

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.^[2]

From 1972 to 1988, he taught at the College of Pharmacy at the University of Illinois at Chicago,^[4] and continues to serve as Adjunct Professor of Biopharmaceutical Sciences. From 1988 to 1996, he worked for Abbott Laboratories as its director of technical affairs;^[4] at the same time, he was a professor of pharmacology at the Aga Khan University Hospital in Karachi.^[4] In 1997, he established his own consulting business, known as Pharmaceutical Scientist, Inc.^[5][4] In 2003, he founded Therapeutic Proteins, Inc. to develop biosimilar versions of biopharmaceuticals, such as filgrastim, erythropoietin, interferon, Pegfilgrastim, adalimumab, and other monoclonal antibodies.^{[citation needed]}

In 2002, Niazi published the first complete translation^[6] of the ghazals of Mirza Asadullah Baig Khan, known as "Ghalib"^[7] and another in 2009.^[8] In 2023, Niazi published the first complete English translation of Ghalib's Persian love poems with Mariam Tawoosi^[9]

Niazi's primary research subject is the field of biosimilars.^[10] He has published multiple books^{[11][12][13][14][15][16]} on the subject and peer-reviewed research papers^{[17][18][19][20][21][22]} that advise developers on how to secure a faster approval of biosimilars by the FDA and EMA and suggest changes to harmonize approval guidelines.

On 14 August 2012, the Government of Pakistan announced that President Asif Ali Zardari would be awarded the Sitara-i-Imtiaz in Engineering Science to Sarfaraz.^[23]

• Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues. Boca Raton, Florida: CRC, 2002. ISBN 9780849329913.
• Textbook of Clinical Pharmacokinetics and Biopharmaceutics. Bsp, India. 2010. ISBN 9789381075043.
• Handbook of Bioequivalence Testing. Boca Raton, Florida: CRC, 2014. ISBN 978-1482226379.
• Biosimilar and Interchangeable Biologics: From Cell Line to Commercial Launch, Two Volume Set 1st Edition. Boca Raton, Florida: CRC, CRC, 2015. ISBN 978-1482298918.
• Fundamentals of Bioprocess Engineering. Boca Raton, Florida: CRC, FL. 2015 ISBN 978-1466585737
• Love Sonnets of Ghalib. Rupa Publications, New Delhi, India, 2017. ISBN 978-8129148520.
• Biosimilarlity—The FDA Perspective. Boca Raton, Florida: CRC, 2018. ISBN 978-1498750394.
• Handbook of Pharmaceutical Manufacturing Formulations Volumes 1–6. Boca Raton, Florida: CRC, 2019. ISBN 978-1138103924.
• Handbook of Preformulation: Drugs, Botanicals, and Biological Pharmaceutical Products. Second edition. Boca Raton, Florida: CRC, 2019. ISBN 978-0367705640.
• Future of Pharmaceuticals. A Nonlinear Analysis. Boca Raton, Florida: CRC, 2022. ISBN 978-1138297555.
• mRNA Therapeutics--A Fast to Market Strategy. CRC Press, Boca Raton, Florida. ISBN 9781032163444
• Biopharmaceutical Manufacturing, Volume 1 Regulatory processes. Professor Sarfaraz K. Niazi, Sunitha Lokesh. Bristol, UK 2021. ISBN 978-0750331739.
• Biopharmaceutical Manufacturing, Volume 2 Unit Operations. Professor Sarfaraz K. Niazi, Sunitha Lokesh. Bristol, UK 2021. ISBN 978-0750331777.
• Wine of Love, Persian Ghazals of Ghalib, Translations, and Explications by Sarfaraz Niazi and Maryam Tawoosi^[24] Ghalib Academy of America ISBN 978-0-9714746-2-8.