Sarfaraz Niazi | Chairman, Professor
Karyo Biologics/UIC

Sarfaraz Niazi, Chairman, Professor, Karyo Biologics/UIC

Professor Sarfaraz K. Niazi, Ph.D., FRSB, FPAMS, FACB, SI, Executive Chairman, Karyo Biologics and PharmSci, is a globally recognized pioneer of the pharmaceutical and biopharmaceutical industry, with 50+ books, 100+ research papers, 100+ patents, several approved CPs to FDA, dozens of crafted regulatory guidance, and the experience of taking many pharmaceuticals and biosimilars through regulatory approval across globe, raising hundreds of millions of dollars. He has now embarked on a global effort, in collaboration with regulatory agencies, to revolutionize the the current archaic approval process for generics and biosimilars, making it more relevant on contemporary scientific concepts—all with a goal to enhance accessibility to safer medicines. These concepts include a thermodynamic approach to compare products and a clinical approach to allow substitution without unnecessary human testing. He is an in inductee into Entrepreneur Hall of Fame, and the Forbes Magazine, Chicago Tribune and many other publications calling him “the most interesting man in the world changing healthcare.” He serves on the faculty of several major universities and is a fellow of several most prestigious learned societies. (;;


Biosimilars Day 2 - Tuesday 30th October 2018 @ 09:00

The New FDA Biosimilars Action Plan—What to Expect?

  • Time to revisit the scientific rationale for approving generics and biosimilars—breaking out from tradition and rote practice
  • Encouraging fast to market approaches—a challenge for both developers and FDA
  • Making “what is clinically meaningful” truly meaningful-- a new class of substitutable biosimilars and compliant generics

Biosimilars Day 2 - Tuesday 30th October 2018 @ 10:00

Biosimilars: Current requirements and experience with EU and FDA approvals

Panel Discussion on regulation followed by questions from the audience
last published: 29/Oct/18 16:25 GMT
last published: 29/Oct/18 16:25 GMT

back to speakers

There are two parts to the Festival of Biologics: the five world-class international conferences covering Antibodies, Immunotherapy, BioSimilars, Clinical Trials, and High Potency APIs; and an exhibition featuring the most exciting technology and solutions for pharma and biotech. There is a registration fee to attend the conferences. To visit the exhibition is free.


Conference 29 - 31 October • Exhibition & Seminars 29 - 31 October

Sign Up for Event Updates