Prescribing practices for biosimilars: questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico

Abstract

Introduction: World Health Organization (WHO) recommendations for the regulation of biosimilars form the basis of guidelines used across most of Latin America. However, the pace at which the region moves toward reaching its potential of having safe and eff ective biosimilars has been slow. The Alliance for Safe Biologic Medicines used a questionnaire to survey a sample of Latin American prescribers in order to determine what they understood about biosimilars, how they use them, and their concerns for the future. Methods: A 15-minute web-based survey in their native language was sent to a total of 6,650 prescribers in four countries in Latin America: Argentina, Brazil, Colombia and Mexico who were off ered US$75 to complete the survey. Responses obtained from a total of 399 (6%) of these physicians were translated into English for analysis and reporting purposes. Results: A total of 88% of respondents from all the countries said that they prescribed biological medicines although 35% did not consider themselves familiar with biosimilars. Nearly a third (30%) of respondents across all the countries surveyed were not aware that a biosimilar may be approved for all the indications of the innovator product on the basis of clinical trials in only one of a limited number of those indications. This varied by country: 37% of respondents claimed to be aware in Argentina, whereas only 23% of respondents in Brazil. How medicines are identifi ed, and how biologicals were identifi ed when reporting adverse events (AEs), was found to vary between countries. Respondents were split evenly between those that believed switching between biologicals with the same nonproprietary name was safe and would achieve the same result, and those that did not. A total of 75% of respondents claimed to be aware that the WHO has proposed adding a four-letter suffi x called a 'Biological Qualifi er' to the non-proprietary or scientifi c name of a biological. A total of 94% of respondents thought such a suffi x would help ensure that their patients received the right medicine. Conclusion: A total of 399 respondents (6% of those who were sent the questionnaire) were recruited from four Latin American countries for the survey. Reported prescribing practices varied across the region, and reveal gaps in understanding and in the use of distinguishable names for biologicals. Nearly all the Latin American physicians who completed the survey supported the WHO's Biological Qualifi er proposal.

Physicians’ perceptions of the uptake of biosimilars: a systematic review

“…Physicians' perceptions of biosimilars have been studied mainly in Europe (n=16) 10 17-30 and North America (n = 4). [31][32][33][34] Single studies have been conducted in Australia (n=1), 35 New Zealand (n=1), 36 Central and South America (n=1) 37 and with participants from multiple African, European and Middle Eastern countries (n=1) 38 (table 2). All the studies were published between 2014 and 2019, most of them (n=20) 10 17 20-22 24-38 in 2017 or earlier.…”

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

“…45,84,144 In a survey of prescribers in Argentina, Brazil, Colombia, and Mexico, approximately half of respondents claimed that they either reported AEs for biologics rarely (25%) or reported only some AEs (28%); 9% stated that they never reported AEs. 28 As such, a cultural shift may be required in the medical community towards giving greater importance to reporting AEs. 145 …”

“…In the aforementioned survey of Latin American prescribers, for example, more than a quarter (28%) of the respondents stated that they identify a biologic by its non-proprietary or generic name when reporting AEs. 28 Furthermore, only approximately half of respondents (51%) claimed that they consistently use batch numbers when reporting AEs. 28 In the longer term, it is conceivable that supply chain enhancements designed to track legitimate medicines from manufacturer to patient, thus defending against the infiltration of counterfeit products, could also aid pharmacovigilance for biologics, by benefiting batch-level traceability.…”

“…28 Furthermore, only approximately half of respondents (51%) claimed that they consistently use batch numbers when reporting AEs. 28 In the longer term, it is conceivable that supply chain enhancements designed to track legitimate medicines from manufacturer to patient, thus defending against the infiltration of counterfeit products, could also aid pharmacovigilance for biologics, by benefiting batch-level traceability. 149 Argentina has already implemented a drug traceability program, 150 and a pilot involving barcoded medicine packs is due to take place in Brazil during 2018.…”

“…In a recent survey of physicians in Argentina, Brazil, Colombia, and Mexico, 88% of whom reported prescribing biologics, more than one-third of respondents did not consider themselves familiar with biosimilars. 28 This review thus provides an overview of the biosimilar concept, the biosimilar landscape in Latin America, and the key biosimilar mAbs and fusion proteins that are in development or have been approved globally. These biosimilars, which are likely to reach the Latin American market in the near future, are relevant to clinicians specializing in either oncology or the treatment of immune-mediated inflammatory diseases.…”