On June 29th, ASBM Chairman Harry L. Gewanter, MD and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave presentations at the 6th Latin American Forum on Biosimilars, held in Brasília, Brazil. The event was also the 7th Brazilian Forum on Biosimilars. The event was attended by more than 500 healthcare stakeholders, including patients, physicians, regulators and manufacturers.

Dr. Gewanter presented data from ASBM’s survey of 399 Latin American prescribers of biologic medicines, on matters including biosimilar naming, labeling, and substitution.

The survey found a need for education about biosimilars among the physicians surveyed, all of whom prescribe biologics. Only 12% of respondents considered themselves “very familiar” with biosimilars, with more than a third (35%) having never heard of them or being unable to define the term.

 

Dr. Gewanter discussed two distinguishable biologic naming proposals by the FDA and World Health Organization (WHO) that would ensure clear product identification between similar medicines, allow an accurate patient record to be kept, and promote accurate tracking of adverse events.
The survey showed that 94% of respondents considered the WHO’s proposal, a four-letter suffix called a “biological qualifier” or BQ, “helpful” in ensuring their patients receive the correct medicine.

 

Mr. Spiegel presented the patient perspective on biosimilars, emphasizing the need for high and consistent approval standards, transparency in labeling and during substitution, and the importance of  control of treatment decisions remaining between a patient and his healthcare team from whom he or she receives direct care.

Mr. Spiegel cautioned against the non-medical switching of a patient’s medicine, arguing that there is no reason for a physician to switch a medicine that is working effectively for a patient. The patient’s health and safety should always be the primary consideration.

Dr. Gewanter’s presentation may be viewed here.

Mr. Speigel’s presentation may be viewed here.