Comparison of the cost of development of biologicals and biosimilars

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

Comparison of the cost of development of biologicals and biosimilars

Home/Reports | Posted 11/03/2022 0 Post your comment

The high cost of pharmaceuticals, in the case of biologicals, has a growing impact on healthcare costs worldwide.

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].

Table 1: Comparison between the development of different drugs

	Investment	Approval time	Number of patients in studies
Generic drug	US$2 million–US$3 million	2 to 3 years	20 to 50 patients
Biosimilar	US$100 million–US$200 million	8 to 10 years	500 patients
Originator biological	US$800 million	8 to 10 years	800 to 1,000 patients

Source: ANAHP Brazil, 2018.

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.

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

LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Nomenclatura de biológicos y biosimilares en Argentina Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Nomenclatura de biológicos y biosimilares en Argentina !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.