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The Brazilian generics market Posted 09/05/2014

Generics are an effective tool to provide affordable, safe and reliable medicines to patients in Brazil, according to a presentation by Telma Salles [1].

Brazil is big. A population of 186 million makes it a huge country and a huge market. The Brazilian pharmaceutical market is the third largest in the Americas region, behind Canada and USA [2]. It ranks first in the Latin American region and is estimated to have a value of US$26,521 billion.

Brazilian Law 9.787/99 provides for the registration of generics in the country. The law introduced the concept of bioequivalence with reference products and enabled the launch of the first official ‘interchangeable’ generics in Brazil in February 2000. Before the introduction of the generics law, branded generics, which could be obtained either with or without a prescription, were the only alternatives to originator drugs.

In Brazil, generic medicines by law have to be 35% cheaper than the reference product, and in practice they are generally 60% cheaper. It is already possible to treat about 90% of the most common human diseases with generics. Among the 20 top prescribed drug products in Brazil, 15 have a generic drug alternative. A total of 76% of medicines dispensed in Brazil are generics. Generics have provided cumulative savings of more than BRL41 billion (US$21 billion) for the Brazilian population in the private market alone.

Looking to the future, biologicals are the next target for savings by the Brazilian Government. Almost 50% of the Ministry of Health’s total expenses on medicines are for biologicals, accounting for around US$3.9 billion per year, despite representing only 5% of the drugs purchased. The Government, however, wants to shift production to domestic firms, in the hope of generating US$225 million in savings per year. The Ministry of Health has organized a Productive Partnerships for Development [Parcerias para o Desenvolvimento Produtivo (PDP)] initiative in order to encouraging domestic production of biologicals by stimulating innovation, technology transfer and development of Brazil-based companies. To date, such arrangements should allow 25 biologicals to be manufactured locally [3].

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References
1. Salles T. Review and market trends III: emerging markets - Brazil. IGPA 16th Annual Conference, Brussels, Belgium, 9-11 December 2013.

2. GaBI Online - Generics and Biosimilars Initiative. The pharmaceutical market in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www.gabionline.net/Generics/General/The-pharmaceutical-market-in-Brazil

3. GaBI Online - Generics and Biosimilars Initiative. Merck Serono to transfer technology for six similar biotherapeutic products to Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www.gabionline.net/Biosimilars/News/Merck-Serono-to-transfer-technology-for-six-similar-biotherapeutic-products-to-Brazil

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