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Fiocruz produces the country's first generic drug for hepatitis B


Tatiane Sandes (Farmanguinhos/Fiocruz)


The Institute of Drug Technology (Farmanguinhos/Fiocruz) has started the production of the first generic drug in the country to treat chronic liver infection caused by the hepatitis B virus (HBV). It is the Entecavir 0.5 mg, an antiviral drug that aims to reduce the risk of disease progression in patients and its complications, such as cirrhosis, liver cancer and even death.

The production is the result of a cooperation with the Ezequiel Dias Foundation (Funed), undertaken in 2019, which defines Farmanguinhos/Fiocruz as the drug's manufacturing site. The laboratory located in the Brazilian state of Minas Gerais is responsible for the packaging and distribution process in the Unified Health System (SUS). Prior to this partnership, the product used to be imported from the United States.

The Institute has already sent the first batches, with more than 670,000 coated pills. In total, by the end of 2020, 5.950 million pharmaceutical units of Entecavir will be delivered.

Funed's president, Maurício Santos, underlines the relevance of this partnership and the national production of this antiviral drug. "We believe that this is our achievement for the Brazilian healthcare industrial complex, so important to ensure that our population has access to quality treatments", he points out.

Epidemiological data

Hepatitis B can be transmitted through contact with contaminated blood, unprotected sex, sharing personal items and sharp objects and also from mother to child (vertical transmission). According to data from the Ministry of Health, 13,992 cases were registered last year, which represents 7 cases per 100,000 inhabitants. Currently, more than 37,000 people are undergoing treatment.

According to the director of Farmanguinhos/Fiocruz, Jorge Mendonça, with this partnership, the drug becomes more accessible to the population and to governments, who can make it available through their public health policies, since it is now manufactured nationally, from the production of the Active Pharmaceutical Ingredient (API) to the final product.

"Thus, we have worked to strengthen the industrial healthcare complex and developed and internalized technology in the country," notes Jorge Mendonça, director of Farmanguinhos/Fiocruz. "With that, once again, the Institute reiterates its technical efficiency and its commitment to quality and public health nationwide, always working to promote life and supply SUS [the Brazilian Public Health System]," points out Mendonça.

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