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Can we foresee pharmaceutical markets dominated by biosimilars in future?

Image credit: https://consultqd.clevelandclinic.org/generics-and-biosimilars-in-multiple-sclerosis-navigating-a-new-therapy-landscape/

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Kritika Bansal Nov 12, 2020
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Food and Drug Administration (FDA) defines a biosimilar as a biological product with high similarity (but not identical) with no clinically significant differences in terms of potency, safety and purity with respect to the already existing FDA reference product. The biosimilar needs to even have the same mechanism of action, route of administration, dosage, strength, and therapeutic indication as its reference product.

Why biosimilars were introduced?
Biosimilars are way affordable than the original product. They cost up to 30% less than their reference product and make up for the product supply in the market when the patents for the original product expires at an affordable rate to the patients. This not only makes the treatment cheaper but more accessible across people from different economic strata. Biosimilars also will encourage competition in the market and reduce the long-term monopoly by the pharma giants.


With the current regulations laid down for biosimilars that require extensive data to demonstrate biosimilarity, and lack of awareness at the global level, can we foresee biosimilars getting easy entry in future? Will biosimilars be accepted by the patient at the same level when introduced mid-term of a treatment?

It would be interesting to see the action that biosimilars could bring!

[1]Konstantinidou, S., Papaspiliou, A., Kokkotou, E."Current and future roles of biosimilars in oncology practice (Review)". Oncology Letters 19.1 (2020): 45-51.

[2]Kim, HoUng et al. “The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases.” Drugs vol. 80,2 (2020): 99-113. doi:10.1007/s40265-020-01256-5

biosimilarbiotechmedication
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Creative contributions

Questions first: But why are they different if they have the same clinical properties?

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Subash Chapagain
Subash Chapagain Nov 13, 2020
It would be really nice, as seen from the consumers' point of view, to have some viable options for present-day pharmaceuticals. More than often, especially in those parts of the world where the public health system is not in the immediate grasp of the governments (or public institutions), cost and affordability become a major barrier to enhanced health. We have often heard/seen stories of people going bankrupt due to the cost of the health-care service and products that are needed for themselves or someone in the family. If biosimilars are equally effective and less costly, they might help alleviate this problem. However, it is obvious to have some concerns regarding the safety, efficacy and acceptability of these products. The mainstream drugs that are being administered and prescribed in the present health-service market were not developed overnight. They had to go through some rigorous research and development phase and clear through all phase I, II, and III clinical trials before they were considered safe for the use in human patients. In this regard, in what stage are we with Biosimilars? Are there any such proven products that have been scrutinized and that have passed all these phases of testing so that they can be thought of as alternatives to the pharmaceuticals? Another thought that crosses when hearing about such alternative products is how are they different than the drugs available commercially in terms of their pharmacological properties? Or is it just the price that makes them different? If they are cheaper, why are they cheaper? What part of present-day drug-production systems seem redundant as compared to the biosimilar products? Rather than seeking for a complete replacement of the drugs available today, can we think in lines of reducing the process and production costs of these drugs taking reference from the biosimilars, all the while guaranteeing the same clinical efficacy and safety?
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no easy entry, as everything new

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Martina Pesce
Martina Pesce Nov 13, 2020
If biosimilars are the equivalent of the already existing biological product, the only difference that influences the price of the item is then the way in which the biosimilar molecule is produced.
It is true that if a molecule has already gone through the whole trial I, II, and III phases then it should be considered safe and used, but what all these tests verify is never just the pure molecule: it's the pure molecule plus the way in which it had been produced. Every producing process brings along impurity, imperfections, and variabilities due to the chemical processes and to human errors and unreliability.
Even if the molecule is the same, the way it is produced brings along another list of variability that may be completely different from the ones brought by the already approved version of it.

Biosimilars can be "derived from living cells or organisms and consist of relatively large and often highly complex molecular entities that may be difficult to fully characterise. Due to inherent variability of the biological system and the manufacturing process, any resulting biological will display a certain degree of variability (‘microheterogeneity’), even between different batches of the same product." I believe this is a very big source of variability that needs to be verified somehow.


I believe it's prudent and wise to verify all the new biosimilars in the same way as their biological equivalent. It is also essential, though, that research on biosimilars is not slowed down or penalized, exactly because of all the advantages they bring that are mentioned above (low cost with a consequent lower income needed to access therapies, no big pharma monopolies, etc...)

[1]Biosimilars: what clinicians should know. 2012, 120 (26):5111-7 Blood

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I imagine a bit of patients resistance

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Martina Pesce
Martina Pesce Nov 13, 2020

These days people are very skeptical of everything which is given to them as medicine.
Conspiracy theories are at their best thanks to the internet and social media and anti-vaccine movements are an example . Also, everything which is not directly derived from natural products these days is not very well seen.

Given this, I can imagine patients may have some resistance in taking biosimilars instead of the biological equivalent.
I don't think it would be something as problematic and diffused as anti-vaccine protests, though. This is because biosimilars are mainly produced for therapies that are not so widely used and diffused, such as monoclonal antibodies for cancer. This would not really allow big groups of protestants patients to come together and protest.

[1][1] E. Dubé, M. Vivion, and N. E. MacDonald, “Vaccine hesitancy, vaccine refusal and the anti-vaccine movement: Influence, impact and implications,” Expert Review of Vaccines. 2014.

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