The Executive branch is being criticized for having enabled the use and prescription in public hospitals of the biosimilar medicine for oncological treatments of Argentine origin Bevacizumab. It was enabled with the recognition of the Argentine health authority (National Administration of Medicines, Food and Medical Technology) and without the endorsement of the Directorate of Sanitary Vigilance (DVS) of Paraguay. On May 10th, from the Paraguayan Society of Medical Oncology (SPOM) they hardened their claims on this issue. They argue that the drug lacks clinical evidence to ensure its interchangeability with the medications used so far. They demand that the DVS carry out and present the interchangeability and efficiency studies in the coming months.
The SPOM’s claim is caused by the authorization by the Ministry of Health of a four million dollar purchase of Bevacizumab, a biosimilar developed in Argentina to fight, among others, against breast cancer. The Ministry of Health decided to use it because it considers it is a high-quality, low-cost drug.
However, SPOM questioned the use of this new drug, criticizing the scientific adoption procedure used by the Ministry of Health. They claim that the relevant clinical studies have not been made public to ensure the interchangeability, safety and effectiveness of the new drug. They also argue that this drug has not been approved by the Food and Drug Administration (FDA), a US entity specializing in drug testing, nor by its European equivalent, the European Medicines Agency (EMA).
The entity, that brings together oncology specialists, expect that the relevant pharmacovigilance studies will be presented in the coming months. However, this has not been endorsed by the Ministry yet.