But it is important to understand that even if a cost reduction is sought with the biosimilar compared to the originator biological, the same efficiency of economic impact is not reached as it is achieved with the use of generics compared to their references [1].

The manufacture of biosimilars is more difficult than that of traditional small molecule generics, mainly because biosimilars are larger and more complex molecules. This means that they cannot be produced by classical chemical processes, but are produced in living cells, with purification being a critical step in the process [2, 3].

To get an idea of the comparison of development costs for different drugs, as can be seen in Table 1, on one hand, US$2 million to US$3 million are invested to approve a generic drug over a period of two to three years, requiring studies with 20 to 50 patients.

For a biosimilar, on the other hand, it takes US$100 million to US$200 million of investment, eight to 10 years of development and studies with some 500 patients are needed to reach the market.

In comparison, the development of an originator biological product would cost about US$800 million, take eight to 10 years, and 800 to 1,000 patients evaluated in the studies [4].

In healthcare management, the essential parameters are: the economic impact (how the drug, treatment or technology used will impact the overall budget of the institution or company); the incremental cost-effectiveness ratio (how much the new drug, treatment or how the technology will impact the cost and outcome relative to what was previously used for the same disease); and the guidelines for evaluating these new technologies.

Apart from the huge development cost, biologicals and biosimilars face several manufacturing challenges, such as process and product understanding, host cell variability and downstream processing bottlenecks [4]; there are also scientific, legal and regulatory challenges in the development of biosimilars [5].

This article is the last in the series of three articles on the role of biosimilars in health care in the Brazilian context.

Related articles
Market outlook for biological medicines in Brazil 2016-2025

Pharmaceutical market of biological and biosimilar medicines in Brazil

Guide for the comparability assessment of biological drugs in Colombia

Prices for arthritis biologicals in Latin America

Biosimilars as a sustainable option for the health system in Argentina

References
1. Ministério da Saúde (BR). 10a Reunião do Grupo Executivo do Complexo Industrial da Saúde - GECIS. Complexo da Saúde: Parceria para o Desenvolvimento Produtivo [homepage on the Internet]. 2016 [cited 2022 Mar 11]. Available from: http://www.saude.gov.br/ciencia-e-tecnologia-e-complexo-industrial/complexo-industrial/grupo-executivo-docomplexo-industrial-da-saude-gecis
2. GaBI Online - Generics and Biosimilars Initiative. Why is “the process the product” for biosimilars? [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 11]. Available from: www.gabionline.net/Biosimilars/Research/Why-is-the-process-the-product-for-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Amgen explains the steps of manufacturing a biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 18]. Available from: www.gabionline.net/biosimilars/general/Amgen-explains-the-steps-of-manufacturing-a-biosimilar
4. Tafla C. O papel dos biossimilares na saúde. https://www.pcomunic.com.br/forumemsaude-icoi/wp-content/uploads/2021/06/O-papel-dos-Biossimilares-na-saude.pdf
5. GaBI Online - Biopharmaceuticals and biosimilars: manufacturing challenges [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 11]. Available from:
 www.gabionline.net/biosimilars/research/Biopharmaceuticals-and-biosimilars-manufacturing-challenges

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