A Historical Letter to President Obama Advising on Biosimilars
The H.R. 3590 Sec. 7002, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) created a new category of biological products, biosimilars, having a similar safety and efficacy profile as a US-licensed reference product. The BPCIA was approved as part of the Affordable Healthcare Act, after years of politicking in the US Congress without any resolution as big pharma kept pushing its approval. In 2008, when Barack Obama was elected President, I wrote a personal letter to him that is now in the Obama Library in Chicago, where I found the privilege of advising him on the need for this legislation and apprised him on the critical elements of the bill that needed to be kept intact. President Obama was convinced that a seven-year exclusivity period for new biologics should suffice, as I had recommended; but then the political pressure came into play, and he reluctantly agreed to a 12-year exclusivity. The frenzy that preceded the passage of the Affordable Healthcare Act, wherein the BPCIA was a minor add-on, perhaps escaped the scrutiny of many vested interests, yet, some elements that should not have been in the bill, could not be deleted—most prominently, the dual classification of biosimilars, as biosimilars and interchangeable biosimilars, the latter requiring testing that would prove to be irrelevant and scientifically irrational.
I have continued to write about the slow entry of biosimilars to the US markets and continue to hope that someday we will be able to find a rational approach to make biosimilars affordable.
This letter is in the Obama Libraray in Chicago. .
FDA Withdraws its Pivotal Biosimilar Products Testing Guideline After Sarfaraz Niazi, founder of Pharmaceutical Scientist, Files the First Citizen Petition Challenging its Clinical Relevance
In an unprecedented move, the US FDA withdrew its guidelines on the approval of biosimilar products, a multi billion dollar marketplace, after Niazi filed a citizen petition identifying the flaws in the scientific strategies of the guideline. This change will allow faster entry of biosimilars to the market and make them more accessible.
Finally, a book that distills a decade of experience of developing biosimilars; The expectations of FDA are often missed by even the most resourceful companies. Biosimilarity is what the FDA decides using a scientific approach where additional studies, particularly, the clinical studies are minimized. From statistical models, to CQA establishment, to designing bridging studies, this book is one source that no biosimilar develope should do without.
My Most Pivotal Patent
With 100+ patents in bioprocessing, biosimilars testing, NCE, new formulations, wine aging, disease management and more, I am now announcing my most pivotal patent allowed by USPTO two days ago--Windy City Hat--at that will not fly off. I designed placement of holes in the brim to overcome Bernouli's pressure using a DOD IBM Road Runner computer. Ran three clinical trials. And now you will see you Stetsons and cowboy hats that will stay on longer. I have been wearing it for over a decade now.
Launching My Second Biosimilars Company
Now that my first US biosimilars company is fully funded and has reached the commercial stage, I am launching another company, Karyo Biologics, operating in a partnering model, to overcome the physical limitations of every company (even if you are AmgenPfizerSanofi GenzymeAbbVieNovartisMerckGSKBristol-Myers SquibbAbbottDr. Reddy's LaboratoriesBiocon or Celltrion)in expanding its portfolio and in overcoming the inevitable delays due to the peculiar 351(k) regulatory expectations. I am thankful to dozens of major companies around the world who are now part of Karyo and most of all to FDA for giving us prompt responses to our submissions, stating that we are ready to file INDs. We are now the first private label US biosimilars company with a fast expanding portfolio and a proven fast-to-market opportunity for a broader category of distributors. Somehow I continue to believe that we can prove the value of BPCIA to make biosimilars more accessible (available and affordable), if we keep getting creative.
On Leaving the Company I founded
In 2013, I founded Therapeutic Proteins Inc (now Adello Biologics) with a vision of making biosimilars more accessible. Today, my company has products under approval by the FDA, and these products are manufactured using my patented technology. I owe my small success to the graciousness of dozens of angel investors, who gave me a head start, Jim Berens, a man of true class, who placed his trust in my passion to help me build clean rooms, Steve and Daniel Einhorn for risking their venture capital with great heart, and finally, Chirag, Chintu and Tushar Patel, who turned a humble beginning into one of the largest funded biotechnology company in the country. It was a challenging ride, but we came through. Now my company is in good hands with Peter and Mike and it is about time that the baton is transferred to new hands, who are much better at handling supply chain issue than I could. I leave the company I founded with an experience of a lifetime and a sense of immeasurable humility.
A Biosimilar Delayed is a Biosimilar Denied, Dr Niazi to present reasons why biosimilars fail
. Invited presentation at the Regulatory and Development Strategies Biosimilars Markets Access and Commercialization Strategies Summit, Boston September 18-19, The Westin Boston Waterfront. Biosimilar Market Access and Commercialization Strategies Summit provides detailed presentations, intensive case studies and collaborative panel discussions relevant to many fields including biosimilars. Dr. Niazi will be speaking on the topic of why do biosimilar filings fail and how we can manage them to assure fast to market approval, based on his 20+ years of developing biosimilars, writing the largest numbers of books on the subject and holding the largest number of bioprocessing patent in the world that help reduce the development and approval cycle.
Dr. Niazi is providing a unique thermodynamic equivalence insight into Statistical Evaluation of Generic Transdermal Delivery Systems and Tropical Patches, as one of his areas of expertise and plans to participate in several sessions relating to biosimilars. The FDA provides the following comment on the Niazi's session: “With the passage of Generic Drug User Fee Act (GDUFA), there is an increased emphasis on research for generic drugs, especially in the field of statistical evaluation of generic transdermal delivery systems and topical patches (hereafter referred as TDS products). Office of Generic Drugs (OGD) in FDA CDER recommends two types of studies for TDS products Abbreviated New Drug Applications (ANDAs): one is bioequivalence (BE) with pharmacokinetic (PK) endpoints study, and the other one is the skin irritation, sensitization and adhesion study. For skin irritation, sensitization, and adhesion study, the applicant usually conducts two studies, an adhesion study and an irritation/sensitization study. To support regulatory approval, in addition to the bioequivalence of PK endpoints, the test product must adhere at least as well as the reference product, be no more irritating than the reference and be no more sensitizing than the reference. This session will discuss statistical issues, challenges and approaches in the adhesion study and irritation/sensitization study for generic TDS products.”
FDA Opens Portal for Novel Dissolution Testing in Response to Dr. Niazi's Citizen Petition
Pharmaceutical Scientist, Inc.: FDA Calls For Public Comments On Bioequivalence Testing
In a significant move, the US Food and Drug Administration (FDA) is asking for public comments on bioequivalence testing of generic drugs, specifically novel dissolution methods, to allow biowaivers for all types of drugs. The call comes in response to a Citizens Petition filed by Dr. Sarfaraz K. Niazi, Executive Chairman, Pharmaceutical Scientist, Inc., and Adjunct Professor of Biopharmaceutical Sciences at the University of Illinois at Chicago College of Pharmacy and author of dozens of books and research papers on the subject (www.niazi.com).
Dr. Niazi would like to speed the approval process for generic drugs to get medicine to patients as quickly and cost-effectively as possible by using a faster process called thermodynamic equivalence. The FDA has agreed to the validity of Niazi’s argument, in theory at least. In a response letter to Dr. Niazi’s petition, Dr. Janet Woodcock, Director of the Center for Drug Evaluation Research at the FDA, wrote that her department “is largely responsive to your request that we "open comment" on novel dissolution tests that can be used to establish bioequivalence…Therefore, your Petition is granted….” “It has taken years of communication with FDA to reach this stage,” said Niazi.
The focus of expanding biowaivers in the petition calls for establishing a new parameter—thermodynamic equivalence, to obviate the need for blood level studies that significant biologic variability that confounds true differences between products. The suggested change fits well within the purview of the Fair Access for Safe and Timely Generics Act of 2017 or the FAST Generics Act of 2017 and other measures taken by the FDA to allow faster approval of generic chemical and biosimilar drugs. Thermodynamic equivalence demonstration requires identifying dissolution conditions that can discriminate differences in chemical potential, a process created by Dr. Niazi. Thermodynamic equivalence can be used to assure life-cycle clinical equivalence of a generic product and provide a critical measure of GMP compliance.
Now Dr. Niazi is calling on the scientific community to send their feedback to the FDA. “I am encouraging scientists to respond to this challenge and help reduce the cost and time to approval for both chemical and biologic drugs,” said Dr. Niazi. To participate in the public comments, go to https://www.regulations.gov/comment?D=FDA-2007-P-0055-0004 and the correspondence between FDA and Pharmaceutical Scientist, Inc., a global science-driven idea company (www.pharmsci.com).
Bioinnovation: Cost & Time Optimized Development of Biosimilars
At the 4th Annual Biomanufacturibg Summit, Dr. Niazi analyzes the major hurdles, never fully recognized, that have caused delays in approvals and escalated cost of development of biosimilars in USA and offers clear solutions. Read the presentation here.
Dr. Niazi addresses the World Biosimilar Congress 2017
Innovating to Achieve First to Market
Dr. Niazi to present keynote address at 10 Annual Bioprocess Innovation Conference
Title: Bioinnovation of Future for Cost Optimization. Dr. Niazi discloses a complete plan, from facility design to upstream and downstream manufacturing in ISO9 environment, continuous processing and a cost-optimized manufacturing platform that is a subject of dozens of US and worldwide patents owned by Dr. Niazi.
Dr. Niazi presents his pivotal talk, "Reinventing Commercial Biomanufacturing" at ISPE Europe Biotechnology, October 2016, Frankfurt, Germany.
TheraProteins Executive Chairman Dr Sarfaraz Niazi Chairs 2015 Bioproduction Summit
As the conference chair for the 2015 Bioproduction Summit in San Francisco, California, Dr Niazi lead discussion around the manufacturing and development of biosimilars.
Dr Niazi Inducted into Chicago Area Entrepreneurship Hall of Fame
For three decades, the Chicago Area Entrepreneurship Hall of Fame has been honoring local entrepreneurs that have left their mark on the business community and the city of Chicago
Dr. Niazi, Distinguished Speaker at IBM Research, California
IBM Research and the Accelerated Discovery Forum invited Dr. Niazi as Distinguished Speaker at the IBM Research Distinguished Seminar Series on 9th April 2015. Dr. Niazi spoke of the changes in biological processing hat are coming to accommodate the new types of biological drugs and the need to develop these drugs on a faster path. A copy of his presentation is provided here.
The Most Interesting Man Revolutionizing The Health World
He wrote his first world-renowned book at the age of 26. On weekends he recites love poems (ghazals) on Voice of America. He casually – and humbly – references his more than 70 patents that range from aging wine to chewing gum to bioreactors...
The man that Forbes considers the most revolutionary for health in 2014
CEO of Therapeutic Proteins International, the Indian Sarfaraz Khan Niazi is a defender of the popularization of biosimilars as an alternative to rising health costs...
How an inventor's trying to cut the cost of making biological drugs
The 2010 Affordable Care Act created a shorter licensing path for lower-cost versions of cell-derived drugs called biologics. Sarfaraz Niazi is working to get among the first of these substitute drugs called biosimilars approved...
Medicine or food? Both, is this startup's mission
Sarfaraz Niazi grew up in India and, as a pharmaceutical consultant later, visited impoverished countries where families sometimes had to choose between buying medicine for one child or food for them all...
Illinois Governor congratulates Chicago Scientist named to receive civil award from President of Pakistan
Illinois Governor Pat Quinn congratulated Dr. Sarfaraz K. Niazi, a long-time Illinois resident, for being awarded the Pakistani civil award Sitara-i-Imtiaz (Star of Excellence) announced on Pakistan's Independence Day...
Dr. Niazi Wikipedia Profile
An amazing man, in fact, the most interesting man in the world! No joke!
Niazi Invents a Coating to Reduce Absorption of Food to Prevent Obesity
The New York Times and thousands of other newspapers, television stations and radio stations reported the breaking news about the ground breaking invention of Dr. Niazi, (patented as US Patent 4,530,936 titled “Composition and Methods of Inhibiting Absorption of Nutritional Elements from Upper Intestine” ) that helps manage the most significant health issue, obesity; the invention works by drinking a tasteless liquid, perfluoroctylbromide, a completely safe fluorocarbon that coats the intestine and prevents absorption of food calories. The invention could save hundreds of billions of dollars going into treating diseases such as diabetes, heart disease, cancer and many more.