Sarfaraz Khan Niazi is not the typical CEO. Do not expect the traditional picture wearing a tie, suit, arms crossed, in the usual leadership pose. Niazi’personality has the perfect reflection in his image. The mustache, the hats and the suspenders are closely identified with the posture of the man whom Forbes considered “The Most Interesting Man Revolutionizing The Health World” in 2014.
Native of Lucknow, northern India, Niazi is the president of Therapeutic Proteins International (TPI) – a global holding company in the manufacture of recombinant medicines, also known as biosimilars. Considered the newest frontier of the pharmaceutical industry, this market has been causing a furor in the health trade for its disruptive capacity to provide drug solutions at an infinitely lower cost. And Niazi and his companies are the personification of this process. Recently, the businessman, writer and researcher based in Chicago for over ten years, has released a new book, dedicated to his “friend Barack Obama.” He describes his efforts to make medicines affordable for the Affordable Healthcare Act, the “Obamacare.” To that end, he suggests that the US president terminates bioequivalence testing to approve generic drugs. Instead, the government should use orthogonal equivalence testing methods, which would substantially reduce the cost of introducing equivalent drugs. As a result, Niazi argues, this would substantially increase the quality of products on the market. The objective would be to increase access to biological products, which are very expensive and of high complexity, for those who can not afford it.
I had the chance to interview him in November, 2014 and I wrote a profile of him that was published in Portuguese. Here is the original interview.
Forbes called you “The Most Interesting Man Revolutionizing The Health World.” Do you agree that you are a revolutionary or at least have a revolutionary side?
Sarfaraz Niazi – Judgment is in the eye of the beholder. In our own humble way, we all try to make a small change in the world we have come into and want to leave it a better place when we depart. I am doing all I can to achieve this goal. The difference between evolutionary and revolutionary is merely the timescale.
When Forbes considers you the most interesting person in the world of health, do you believe that has a lot to do with your characteristics – poet, writer, teacher, photographer, radio host, inventor, scientist, and your expertise in chemistry, pharmacy and marketing?
SN – To experience the myriad aspects of life proves rejuvenating to me. I have always questioned everything I see because I realized very early in my life that there is no absolute standard to anything, from morality to literature to science and creative art; standards are merely customary. And, with every question that I get answered many more appear. It is almost like being a child exploring the Universe around. I stay a child in my inquiries and find that to be the most satisfying experience. Getting involved with such diverse activities as conducting a radio program that goes out to billions to photography to recombinant manufacturing, I find these diversities challenging but exciting when I am able to switch my roles—otherwise life becomes very boring.
Your books are distributed in developing countries at a lower price because they are “royalty free”. Your goal with the development of biosimilar medicines is to provide medicine like your books, low cost?
SN – Our goal is to expand access to highly complex, very expensive biologics to those that cannot afford them. We believe in providing affordable, high quality options to patients in need around the globe. Charity begins with a charitable heart and we will always give what we can.
It would be logical that the big pharmaceutical see you as “unfair” competition, but some of your investors are linked to pharmaceutical companies as Amneal Pharmaceuticals LLC? Do you think this means (some) labs are interested in producing inexpensive health solutions?
SN – The main driver for the creation of biosimilars and biosimilar regulations in countries is to provide competition to products that have been to date, monopolies. Similar to small molecule drugs expecting competition once patents have expired, biologics will face the same competition. It is not about being unfair but about giving patients alternatives once IP protection runs out. TPI is an independent company founded on that singular goal of helping the world and we shall continue our vigil.
The biosimilars are usually authorized several years after reference biological medicinal product approval, as the reference medicinal product benefits from a period of exclusivity during which the biosimilar medicines can not be allowed. This may delay the benefits that you want to provide?
SN – Just like any follow on pharmaceutical whether generic or biosimilar, a manufacturer has to wait until the patent protection expires to launch. There is a different kind of benefit provided by an innovative new product that a company invests a lot of money in to bring to market and the patent protection those products get reflects that investment.
What is the difference in production costs between the reference drug, generic and biosimilar? And the sale price to the public?
SN – This will be very depending on the market and company selling the product. In general it takes on average $1-3B to develop a new pharmaceutical, $100-300M to develop a biosimilar and $1M to develop a generic. Pricing in the market will reflect those differences in development costs.
Is the business of Therapeutic Proteins International profitable? It is comparable to a pharmaceutical?
SN – TPI is working on a robust pipeline and expects to launch products in the near future. The business model is totally different from the pharmaceutical product universe; we are making large investment in educating the prescribers and payers of the value of biosimilars.
What about the doctors’ opinion? What feedback have you gotten from doctors regarding your creations?
SN – We have solicited a great amount of feedback from prescribers and users of biologics. Generally, people in the United States are ready for biosimilars and recognize the benefits to patients and to the health care system. Feedback has been very positive. Unlike small molecule drugs where even 70-80% price reduction translates into few dollars, even a small reduction in the cost of biological drugs will make huge total dollar impact. We anticipate that once the doctors are given proper education about the robustness of the regulatory process and a better understanding about the safety of these drugs, the switch to biosimilar drugs will be automatic. As an example, France has, by legislative action made these product interchangeable for new patients. The future market of these products will be driven mainly by the payers.
Besides biosimilars, you have also created a much more economical way to produce drugs, a disposable container that replaces the metal containers. Could you explain the main difference(s) and how it works?
SN – Our process allows for the simultaneous production of numerous products in a relatively small facility with quick scale up. It eliminates the majority of the capital investments needed to develop a more traditional biologic facility. This technology opens a new possibility for the small developers of new drugs including academic institutions, governments and in situations where disaster-related drugs and vaccines are needed to be produced on demand. The key differences between our technology and the standard technology is: completely disposable, no cross-contamination, gentle treatment of living entities to produce a consistent product, extremely cost effective for start up and maintenance, very easy to switchover between batches and highly portable.
Do you believe biosimilars and other inventions that aim to lower the cost of health care would work in most developed countries wishing to reduce their costs with health services?
SN – Absolutely. There is always room for ingenuity and streamlined process in the health care space. To date, developed nations such Europe, Australia, Japan and Canada all have approved biosimilars on market and have been using them safely for years. The issue of affordability remains same for all countries; even in the US, a significant number of patients undergo financial challenges when required to use these products. In the US, a significant cost is paid by the government and billions of dollars of savings are anticipated with biosimilars coming to the US markets.
Do you have any idea of how many people can be benefited if your inventions – biosimilars and the container – are approved?
SN – Currently, biologics realize around $160B in sales globally, representing millions of patients. The potential impact of more accessible biologics is huge and millions and perhaps billions of people around world would be affected. With lowered prices, many more millions will be able benefit from these products who are not currently able to afford them, vastly expanding the market of these products.
And can you imagine how many people have been influenced by your inventions so far?
SN – My inventions always seek to provide practical value and numerous inventions have been put into practical use in various parts of the world. The real use of inventions is when the patents expire so mankind can benefit. A patent simply asserts that the invention is useful, unique and nonobvious. I hope these inventions will find greater use with spin-off devices that will arise including potable water, prevention of hospital-based infections, improved safety of automobiles and very high quality of wines that are affordable as well. The biggest influence I have been able to gather is motivating the young people to be creative, to think different and to challenge everything. And that is more rewarding than any other gain.
I could see by your blog that you are a thinker, so I would like to know what is your opinion about The Affordable Care Act.
SN – The Affordable Care Act was put in place with a similar mission, to allow all patients access to care and to bring down health care costs that are on an unsustainable path. Getting a law passed with that aim is no small feat and TPI is under the impression that patients that need access should get access. That is part of our mission as well.
Related to that, health insurance exchanges are having amazing projections to 2015. As someone concerned with the reduction of health care costs, what would you invent to help people or businesses save on insurance?
SN – Due to the complex nature of the healthcare system in the United States, insurance will also be complex but efforts to make the system more competitive will benefit the people. Additionally, preventative care mandates and the access of preventative care to a wider population has the potential to reduce the burden to the system.
Do you think it is possible to have a free and universal national healthcare system in the US?
SN – There are no free healthcare systems anywhere in the world today. In the U.S. the cost is shared by employers, patients and the government. In other places healthcare is covered by the government but the cost is shouldered by tax payers. Healthcare in the U.S. will stay a mixed system for the foreseeable future. It works very well and with the Affordable Healthcare Act it will become more universal and therefore more affordable.
How do you analyze the future challenges of the health system in developing countries like India or Brazil?
SN – There are challenges with health systems in developing countries. On one had, emerging nations find ways to do more with less. In another the quality of pharmaceuticals and care is not the same as in more developed nations in a lot of instances. To bring up the quality standards while keeping treatments costs affordable will continue to be a challenge going forward. It is unfortunate that some regulatory agencies apply the same quality standards to biological as they do to small molecule drugs and as a result, the damage to patients may be much more severe than otherwise imagined. In my new book, “Biosimilars and Interchangeable Products—from cell lines to commercial launch” that is under printing and the book, “Handbook of Bioequivalence Testing, 2nd Edition” that was released on 29 October 2014, I provide advise to developing countries on how to formulate robust policies to assure quality of biological drugs. This includes advise on using third party evaluators and ongoing surveillance of products produced locally. The regulatory agencies in these countries can develop a safe pathway but that requires a new thinking.
How do you have time to conciliate all the activities in which you engage? (Please tell me if you have invented a way to make your days last more thank 24 hours).
When you have a passion for something, you find ways to do it more efficiently and to find time to engage in those activities for which you are passionate. Actually 24 hours are more than enough. I am 65 years old, I just ran my first marathon (Chicago Marathon) and am looking forward to many years of enjoying life 24/7.
One last question. Your moustache is your trademark, it is even your Twitter profile image. Is there a story behind it?
SN – It did not start as a trademark. When I got married, 40 years ago, my wife told me to keep it and I did. I have enclosed my wedding picture here. Then I began reading Gorky and saw his unruly moustaches and unruly mind—we kind of have a great biosimilarity in our thoughts.