Introduction: A survey of the views of European physicians on familiarity of biosimilar medicines has demonstrated the need for distinguishable non-proprietary names to be given to all biologicals. Methods: The Alliance for Safe Biologic Medicines recruited 470 prescribers with clinical experience of biologicals in France, Germany, Italy, Spain and the UK to answer questions relating to their experience with these medicines in a 15-minute web-based survey which was carried out in the last quarter of 2013. Results: Of the physicians surveyed, 53% mistakenly felt that an identical non-proprietary name implies identical structure; 61% said that identical non-proprietary names imply that the medicines are approved for the same indications, which they may not be, and 24% said they recorded only the non-proprietary name of the biological product in the patient record. Conclusion:The responses of the European physicians demonstrate the need for distinguishable non-proprietary names to be given for all biologicals. Biosimilars, in contrast to generic drugs, have diff erent structures, may have a diff erent therapeutic profi le, and may not be approved for all the indications for which the reference product has been approved.

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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.

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Approximately 25% of all new medicines approved in recent years and in development today are biologicals. The complexity of biologicals, the investment needed to meet ever more stringent regulatory and payer requirements, combined with the needs of an ageing population, mean the cost of these medicines and the burden on governments and insurance companies is growing. However, the introduction of biosimilars has broadened treatment choices for physicians and their patients and, by increasing competition, reduced healthcare expenditures. The biosimilar market in Europe is the largest in the world, representing approximately 60% of the global biosimilar market and growing consistently year on year. As of October 2019, 54 biosimilars of 15 originator biological medicines have marketing authorization in Europe. European countries, with their large biosimilar markets and diverse healthcare systems, serve as valuable examples of different approaches to biosimilar policy. Several studies, research papers and position statements have been published on such policies. These findings, along with real-world policy and procurement examples from European countries, provide an opportunity for other countries to learn from. This paper will review the different approaches to biosimilar policy across the European continent, highlighting principles which can be applied to develop an efficient and sustainable biosimilar market.