BEYOND THE BOOKS
dr. niazi'S bold leap forward
Dr. Niazi’s FDA-acknowledged petition introduces thermodynamic equivalence, to revolutionize generic and biosimilar drug development. This approach streamlines approvals, ensuring safer and faster access to essential medications.
"Every living thing and every moving object owe their life and motion to another entity."
Founder & Inventor
Dr. Sarfaraz K. Niazi
DEVELOPMENT FOR ACCESSIBILITY
fast to market biosomilar
After spending over two decades in developing biosimilars, from cell line to market, that included cytokines, hormones, antibodies, and many more, and after writing several pivotal books on the subjects, I have come to realize that “a biosimilar delayed is a biosimilar denied,” and there is a dire need to rethink the development model for biosimilars that does not cost hundreds of millions of dollars and many years.
I am now developing several biosimilars using this model and invite inquiry if you are interested in acquiring technology, or supply of finished products and any level of regulatory involvement
MY APPROACH
the path to Innovation
Dr. Niazi's core philosophy: "A biosimilar delayed is a biosimilar denied." We eliminate unnecessary steps without compromising safety.
01
Selecting the right product
Biosimilars are classified into three categories, from the fastest to longest to market based on FTO, technical complexity, clinical design, and cost. I have developed a proprietary model to shortlist products, even if you do not have any financial constraints. There is always a way to do things smartly.
02
Complete 351k filing map
The FDA guidance provides a mapping opportunity, that will always be molecule-specific. Getting the most out of the meetings reduces the development timeline. With years of experience, I can help develop a mapping that could provide a timeline and cost line earlier in the development stages.
03
review of bla
While the CMC/GMP remains the key component, a 351k approval requires an entirely different perspective on demonstrating biosimilarity–how to decide what to present, and how to present makes a big difference that one understands through a scientific approach and experience of applying these metrics.
04
bioprocessing Innovations
Writing meeting requests takes a good understanding of science and a better understanding of the art of communication. After writing dozens of books on this subject, I can show you how to make these meetings conclusive, not just informative. As a patent law practitioner and as someone who has written most on bioprocessing, I have created a team of patent law experts to provide an FTO that is specific and conclusive.
05
351k and 505(b)(2) Submissions
The 351k approval is mostly dependent on demonstrating at least a high similarity if not a finger-print similarity. Creating a tier-based statistical model requiring CQAs is critical and so are novel analytical methods; know that FDA is always responsive to creativity. Till 2019 end we have a window of opportunity for several biological drugs to be filled under 505(b)(2); how this filing differs from 351k and how you can make the mandatory fee submission with the first meeting is important to understand.
FACILITY DESIGN
gmp manufacturing facility
The FDA and EMA have adopted a risk-based GMP stance that requires a fresh look at how the GMP facilities are designed including the HVAC systems, area separation, and point-of-use compliance to reduce the cost of constructing and maintaining facilities. The design technology includes:
- Patented HVAC Design to Reduce Cost by 70-80%
- Single-Use Systems to Reduce Utilities
- Continuous Automated Compliance
GALLERY
the man bEhind the mission
MEDIA & COVERAGE
in the prEss
Latest News, Articles and Insights featuing Dr. Sarfraz K. Niazi and his contributions to the Biotech Industry.
INDUSTRY NEWS
Big Pharma's Exit From Biosimilars May Be Imminent
Biosimilar developers are targeting blockbuster “Big Pharma” biologic originator companies.
FDA UPDATES
Scientist Invented A New Pathway To Approve Biosimilars
And The FDA Is Listening. Analysis of how Niazi’s petitions are forcing a re-evaluation of biosimilar testing guidelines.
LETTER
A Historical Letter to President Obama Advising on Biosimilars
Looking back at the strategic advice that helped shape the modern biosimilar framework.