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Filgrastim follow-on biological approved in Brazil Posted 29/01/2016

Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 20 October 2015 that it had approved the follow-on biological medicine Fiprima (filgrastim).

The product, which is manufactured by Eurofarma Laboratórios (Eurofarma), is reported to be the first follow-on biological product manufactured entirely in Brazil or in Latin America.

Fiprima is a follow-on biological version of Amgen’s Neupogen (filgrastim). Neupogen lost its patent protection in the US in December 2013 and in Europe in 2006 [1].

Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy for cancer treatment.

Brazil’s National Cancer Institute (Inca) estimates that in Brazil alone there were 580,000 new cases in 2015, while worldwide more than 12 million people are diagnosed with cancer each year.

According to data from Eurofarma, Brazil’s Ministry of Health spends about 51% of its budget on biologicals. This group, however, only represents 4% of the drugs available by the government to the population.

Through a technology transfer agreement, Fiprima will be produced by Fiocruz and freely distributed by the Unified Health System (SUS). By producing the drug in the country, the Brazilian Ministry of Health expects to save US$9.3 million over the next five years.

Fiprima is expected to be available in the country in the first quarter of 2016.

Editor’s comment
It should be noted that follow-on biologicalapproved in Brazil might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union.  The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product. 

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Reference
1.  GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries 

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Source: Eurofarma

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