From June 26 to 28, 2018, FLAB 2018, the 9th Latin American Forum on Biosimilars, took place in Brasilia. The Laço Rosa Foundation attended the event to follow the development of the debate regarding the theme.
The event promoted round tables to raise issues to be discussed in relation to biosimilars.
The first day was aimed at patients, representatives and journalists, in a pre-forum, to clarify what these medicines are and their differences.
Biological Medicine: the one produced from living organisms and with therapeutic effect.
Generic Drug: identical to the original and synthetic remedies.
Biosimilar Drug: is the one produced with living organisms, when the patent exclusivity period of the original remedy ends. It is not identical to the original.
Because it is not identical to the original, to exchange the biological medicine for its biosimilar, it is necessary to evaluate each case. This means that medical staff should evaluate each patient uniquely in order to define the type of treatment.
According to ANVISA, it is up to the doctor to decide on the exchange for a biosimilar. It is essential to evaluate the efficacy and safety of the drug for the patient.
In countries that are further ahead in relation to the applicability of biosimilars, there is also no consensus or regulation. Each one of them adapts the use of the medicines to their reality. However, the decision of the medical team must be based on scientifically proven data, not on common opinions or practices.