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BioRationality: An Analysis of the Future of Biosimilars Through the Eyes of History


Sarafraz K. Niazi, PhD, previews the new year and his hopes for the end of clinical efficacy testing for biosimilar approvals using examples from history of other scientific concepts that took time to gain traction.

One of the best measures of the rise of science is the PubMed profile of peer-reviewed literature. The first mention of “biosimilarity” was made in 1977, but the text is unavailable. Since then, about 6,000 papers, more than half of them over the past 5 years, have discussed biosimilars. The first clinical trial of a biosimilar was reported in 2007 for growth hormone, and since then, 529 trials have been published, 470 being randomized controlled studies. Now, there are around 1500 review articles and systemic reviews. These gurus tell you what a biosimilar is and rarely present science ahead of their perceptions.

There are 852 clinical trials listed in clinicaltrials.gov, with 300 completed, 190 with results, and 118 with study protocols. Ninety-two thousand subjects were enrolled with a per capita cost of $55,000, leading to an approximate cost of over $5 billion. While this is still smaller than new biological drug development, the biosimilars do not get 12 years of exclusivity. Not surprising is the cost distribution, wherein more than two-thirds of the development cost goes to pay for efficacy trials, making this a significant roadblock for smaller companies entering the market.

solar system | Image credit: WithanTor - stock.adobe.com

Heliocentrism, or the idea of the sun being the center of our solar system, took nearly 2000 years from whenit was first theorized to become accepted as fact. Image credit: WithanTor - stock.adobe.com

I have written extensively on the issue of the redundancy of clinical trials and shared the extensive pharma views that continue to demand this testing as a talking point with prescribers without any risk of failure. It is difficult, as history tells us, to break a belief, mainly when the proposal is contrarian, but I also believe that eventually the scientific principles prevail. Here are a few examples to entertain you:

Ignaz Semmelweis, an obstetrician in 1847, showed that hand washing dramatically reduced mortality in childbirth. Despite this, his ideas were dismissed, and he was tragically institutionalized, dying in an asylum in 1865. His hand-washing practices were not adopted until after his death.

Aristarchus of Samos, in Ancient Greece, proposed a heliocentric solar system around 310 BC, suggesting that Earth and other planets orbit the sun. His ideas were ignored, and Nicolaus Copernicus’ theory reconsidering it wouldn’t be published for another 1800 years.

Gregor Mendel, a monk, established the foundation of genetics in the 19th century. His work on heredity was only recognized 16 years after his death and 34 years after his initial publication.

Lastly, Amedeo Avogadro's hypothesis, now known as Avogadro's Law, proposed that equal volumes of gases contain an equal number of molecules as long as they are under the same temperature and pressure conditions. His hypothesis was initially rejected but gained acceptance by 1870, long after his death.

Before I die, I hope we will come to grips with the reality that testing biosimilars for efficacy testing is just as futile as trying to understand quantum physics, at least for me.

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