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Fiocruz Produces Breast Cancer Drug Trastuzumab for Brazil’s SUS

 Country: BRAZIL | Region: SOUTH AMERICA | Type: Pricing & Reimbursement | Keywords: #bio-manguinhos #breastcancer #fiocruz #oncology #sus #trastuzumab


PRICENTRIC BRIEF:
  • The Oswaldo Cruz Foundation is now supplying trastuzumab to the Ministry of Health (MoH), which distributes the drug to patients free of charge through the Brazilian Public Health System (SUS) to treat a subtype of breast cancer identified by the overexpression of the HER2 gene
  • The drug is supplied by Bio-Manguinhos/Fiocruz through the foundation’s Immunobiological Technology Institute and the supply of the drug is enabled through the Policy for Productive Development Partnership (PDP) and an agreement of technology transference signed with Samsung Bioepsis, owner of the technology, and Bionovis
  • At the end of the PDP, Bio-Manguinhos and Bionovis will produce trastuzumab entirely in Brazil, thus supporting financial sustainability of the Public Health System and strengthening the Industrial Health Complex, a much-needed asset during the COVID-19 pandemic

THE DETAILS

BRASILIA, Brazil — The Oswaldo Cruz Foundation is now supplying trastuzumab to the Ministry of Health (MoH), which distributes the drug to cancer patients free of charge through the Brazilian Public Health System (SUS).

The drug is supplied by Bio-Manguinhos/Fiocruz through the foundation’s Immunobiological Technology Institute. Fiocruz is a pharmaceutical laboratory linked to the Ministry of Health that, in addition to conducting research, is involved in the development and production of affordable and accessible essential medicines.

Trastuzumab is a monoclonal antibody indicated at the SUS to treat a subtype of breast cancer identified by the overexpression of the HER2 gene. It is a biosimilar approved in Brazil since 2019.

The supply of the drug is enabled through the Policy for Productive Development Partnership (PDP) and an agreement of technology transference signed with Samsung Bioepsis, owner of the technology, and Bionovis.

Through the PDP, Bio-Manguinhos/Fiocruz and Bionovis receive the technology from Samsung Bioepsis and incorporate the biosimilar to their portfolios. The first stage is the import, distribution, and absorption of quality control.

The trastuzumab technology transference stages will also include learning and mastering the production process for Active Pharmaceutical Ingredients (API) in pilot-scale at Bio-Manguinhos and, later, ramping up production in industrial scale at Bionovis, strengthening the chain of bio-pharmaceutical innovation in the institutions and in the country.

At the end of the PDP, Bio-Manguinhos and Bionovis will produce trastuzumab entirely in Brazil, settling technology mastership and capacity to supply to SUS product that is 100% national, thus supporting financial sustainability of the Public Health System and strengthening the Industrial Health Complex, a much-needed asset during the COVID-19 pandemic.

The PDP will focus on early and metastatic HER2-positive breast cancer patients in the first line of therapy at SUS, according to the Clinical Protocol and Therapeutic Guidelines of the Ministry of Health.

Approximately 67 thousand new cases of breast cases are estimated per year, of which 20% corresponds to the HER2-positive type, and eighty percent of these cases are treated by SUS.

According to Mauricio Zuma, director of Bio-Manguinhos/Fiocruz, “it is extremely important to be able to help increase free access to women, via SUS, to the treatment of the type of breast cancer most common among Brazilians, with the main drug used for HER2+ cases.”

Odnir Finotti, director-president of Bionovis, said, “to receive and implement the full production technology of trastuzumab, Bionovis is making significant investments on the construction of a world-class industrial plant, on the hiring and training of highly skilled human resources, and on the establishment of laboratories and infrastructure.”

The executive said these measures “will help place Brazil among the countries that have mastership over pharmaceutical biotechnology, a strategic knowledge to ensure that Brazilian patients have access to these drugs and to guarantee the country’s technological sovereignty.”

Finotti called the Productive Development Partnerships a “smart and long-term strategy that has been able to stimulate the establishment of the biotechnological industry in Brazil.”

In addition to the National Authority for Health Surveillance in Brazil (ANVISA), trastuzumab has been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), among others. It was launched in 23 countries and was the first trastuzumab approved in Europe, as well as the only one pre-qualified by the World Health Organization (WHO).

The Institute already has other biosimilars in its portfolio: etanercept, indicated in the treatment of adult patients with autoimmune diseases, such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis; somatropin, used to treat hypopituitarism (deficiency of human growth hormone) and Turner (a genetic condition that causes low height in women); and rituximab, used in the treatment of patients with rheumatoid arthritis and also non-Hodgkins lymphomas.

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