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 effective 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 identified, and how biologicals were identified 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 suffix called a 'Biological Qualifier' to the non-proprietary or scientific name of a biological. A total of 94% of respondents thought such a suffix 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 Qualifier proposal.