The Brazilian Society of Oncology has just published its position paper, which includes the most important points on the approval and use of biosimilar drugs in oncology.
Also included are aspects relating to their definition, nomenclature, extrapolation, interchangeability, automatic substitution, safety, efficacy and potential impact on healthcare budgets.
The Society is in favour of introducing biosimilar drugs as a viable, safe and cost-effective alternative to the biopharmaceutical products currently used in cancer treatment. The objective of the paper is to support the therapeutic decisions that would provide maximum clinical benefit to thousands of cancer patients in Brazil, and help accelerate the introduction of this new class of drugs in clinical practice.
It is the first position paper published by a Latin American oncology society.
In Brazil, the public system is a constitutional right. The Brazilian government is the largest purchaser of biological products in the country, corresponding to 60% of the total purchases.
There are currently 28 monoclonal antibodies available for cancer treatment, with 217 therapeutic indications. Non-Hodgkin’s lymphoma (NHL) is the disease with the highest number of monoclonal antibodies as an indication, and rituximab, which is used in the treatment of NHL, is the biopharmaceutical drug with the greatest number of developed or developing biosimilars.
The high cost of these biopharmaceutical drugs is the biggest expenditure in cancer treatment. However, the introduction of monoclonal antibodies in clinical practice has significantly increased the overall survival rate in cancer patients, while they are generally less toxic and have fewer side effects compared to chemotherapy agents.
In 2019, the patents of the main biopharmaceutical products will expire, opening up a huge opportunity for developing similar biological medicinal products, also known as biosimilars, which could compete and even replace the biological drugs currently available on the market.
Filgrastim, a treatment that stimulates the proliferation and differentiation of granulocytes, is the first biosimilar developed in Brazil, approved by ANVISA (Brazilian Health Regulatory Agency) in 2015.
In the paper, the Brazilian Society of Clinical Oncology takes a position in favour of introducing biosimilars as a viable, safe and cost-effective alternative to current biopharmaceutical drug products in the treatment of severe diseases, especially cancer. They hope that this paper can provide valuable information to support therapeutic decisions that would provide maximum clinical benefit to thousands of cancer patients in Brazil, and contribute to accelerating the introduction of this new class of drugs in clinical practice.
Bibliography:
The use of biosimilar medicines in oncology-position statement of the Brazilian Society of Clinical Oncology (SBOC) G.S Fernandez et al. Braz J Med Biol Res vol.51 no.3 Ribeirao Preto 2018 Epub Jan 11,2018. http://dx.doi.org/10.1590/1414-431×20177214