Sarfaraz Khan Niazi is not a typical CEO. Do not expect a traditional image of tie, suit, crossed arms, the usual pose of leadership. The personality of Niazi has a perfect reflection in his image. The moustache, the hat, and the suspenders are closely identified with the posture of the man which Forbes considers “the most interesting and revolutionary in the world of health in 2014”.
The Indian from Lucknow, a northern region of India, the president of Therapeutic Proteins International (TPI) with global experience in manufacturing recombinant drugs, also known as biosimilars. Considered the newest frontier of the pharmaceutical industry, this market will cause a furor in the health market because of its disruptive capacity in providing medical solutions at an immensely lower cost. Niazi and his companies are a personification of this process. Recently, the businessman, writer, and researcher located in Chicago for more than ten years, published a new book, dedicated to his “friend Barack Obama”.
This work, which is being translated into Portuguese, Niazi describes his efforts to make these medications accessible through the Affordable Healthcare Act, or “Obamacare”. To do this, he suggested the American authorities remove the requirement for bioequivalency tests to approve generic medications. In its stead, the government should use orthogonic equivalency test methods, which would substantially reduce the cost of introducing equivalent drugs. As a result, Niazi asserts, the quality of products in the market will increase substantially. Its objective should be to increase the access to biological products, which are expensive and highly complex, for those who cannot pay for them.
Secondly, he is the founder of TPI, which is an independent company funded with the sole objective of helping the world. “Charity begins with care for people, it’s always important to share what we can,” says Niazi, in an interview with Diagnóstico.
The reduction of the prices of the medicines could make the large pharmaceutical companies consider TPI as an “unfair” competitor, especially since some of their investors are associated with pharmaceutical companies like Amneal Pharmaceuticals, LLC.
DIFFUSION OF BIOSIMILARS – One of the challenges for the popularization of biosimilars is that, normally, their approval is delayed a few years after the expiration of the reference product patent (in Brazil, biosimilars must be called “biologics”, as the original biologics are known as “new biologics”).
To realize the interest of pharmaceuticals in this new market, it would be enough to compare the manufacturing and public marketing costs for a reference product, a generic, and a biosimilar. In general, the costs are between 1 and 3 billion dollars to develop a new reference pharmaceutical. A generic can already be developed with an investment up to 1 million. This is not the case for a similar biologics, whose manufacturing costs are much lower, around 100 to 300 thousand dollars. There are more advantages. Biosimilars save time, the manufacturing time is already reduced in half or a third of that is needed compared to a generic or reference product.
Before the “charity” logic of Niazi and of Therapeutic Proteins International is the question of corporate profitability, but its founder said that the business model is totally different in the universe of pharmaceutical products. “The patients in the United States are ready for biosimilars and recognize the benefits for the health system,” emphasizes the Indian, who hopes to launch his products in the US in the near future. Not coincidentally, the company has been investing in the sensitization of American physicians and consumers on what are the value and virtues of biosimilars. TPI’s prediction is that once physicians receive adequate information on the robustness of the regulatory process and have a better understanding of the safety of these medicines, the switch to biosimilars will be automatic.
Niazi uses France as an example. Since 2014, French law has these products as interchangeable for new patients. “The future market for this type of medicine is advancing principally due to the French contributions,” explains the businessman. He explains that in the specific case of France, the advancement of similar biologics is being accompanied by the creation of much more economical forms of manufacturing medicines.
In Brazil, a study by the Association of Research Pharmaceutical Industry (Interfarma), published last year, reveals that the Brazilian government has invested in manufacturing biologics and has a budgeted estimate of R$ 35 billion until 2016 for the acquisition of medicines.