In Brazil, the Unified Health System (Sistema Único de Saúde, SUS) and the policy of the Ministry of Health (Ministério da Saúde, MS) according to decree GM/MS No. 2.981 of 26 November 2009 grants access to the general population to specialized medicines including some biologicals.

Expenditure on medicines as a whole, and specialized medicines, is constantly increasing in Brazil, see Figure 1. In 2011, 31% of the total amount spent on medicine was for specialized medications including biologicals.

Expenditure on strategic medicines, on the other hand, has reduced. The list of strategic medicines under the SUS is defined according to Decree GM/MS No. 1.284 of 26 May 2010. Strategic drugs are defined as those of higher value, i.e. costing the Brazilian Ministry of Health more than R$10 million per year. Examples of strategic products include filgrastim and somatropin.

Figure 1: Spending on medicines by the Brazilian Ministry of Health

There is therefore an urgent need to combat this increasing expenditure on foreign biologicals. How follow-on biological products as they are called in Brazil, might be produced in Brazil is discussed in the following article.

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Prospects for producing follow-on biological products in Brazil

Brazilian guidelines for follow-on biological products

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Reference

1.  da Silva Madeira L, Borschiver S, Pereira Jr N. Prospects and trends in the Brazilian market for biologically sourced products. J Technol Manag Innov. 2012:7(3);44-56.

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