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Drug prices in Latin American countries: the case of rheumatoid arthritis Biosimilars

Drug prices in Latin American countries: the case of rheumatoid arthritis Biosimilars Background: The objective of this paper is to analyze the prices of biological drugs in the treatment of Rheumatoid Arthritis (RA) in three Latin American countries (Brazil, Colombia and Mexico), as well as in Spain and the United States of America (US), from the point of market entry of biosimilars. Methods: We analyzed products authorized for commercialization in the last 20 years, in Brazil, Colombia, and Mexico, comparing them to the United States of America (USA) and Spain. For this analysis, we sought the prices and registries of drugs marketed between 1999 and October 1, 2019, in the regulatory agencies’ databases. The pricing between countries was based on purchasing power parity (PPP). Results: The US authorized the commercialization of 13 distinct biologicals and four biosimilars in the period. Spain and Brazil marketed 14 biopharmaceuticals for RA, ten original, four biosimilars. Colombia and Mexico have authorized three biosimilars in addition to the ten biological ones. For biological drug prices, the US is the most expensive country. Spain’s price behavior seems intermediate when compared to the three LA countries. Brazil has the highest LA prices, followed by Mexico and Colombia, which has the lowest prices. Spain has the lowest values in PPP, compared to LA countries, while the US has the highest prices. Conclusion: The economic effort that LA countries make to access these medicines is much higher than the US and Spain. The use of the PPP ensured a better understanding of the actual access to these inputs in the countries analyzed. Keywords: Biological products, Antirheumatic agents, Access to essential medicines and health technologies, Products registration, Drug Price Introduction cells whose development is longer and more costly than Rheumatoid arthritis (RA) is a chronic inflammatory that of traditional products. The economic risks involved autoimmune disease that affects 0.3 to 1.0% of the world in this process are high. There is no difference in obtain- population. This prevalence seems to be lower in emer- ing a biosimilar drug, where companies assume the same ging countries, given the differences in age distribution strategic level as those who hold the patents or creators among population groups, difficulty in accessing the of the original biopharmaceutical [3]. Biosimilars are not health system, lack of diagnosis and lack of studies [1]. generic drugs and may differ from reference products in Biological agents used to treat moderate or severe ac- manufacturing, composition and formulation [4]. tive disease reduce inflammation and prevent joint dam- In the US market, few biosimilars are available as a re- age [2]. These are innovative products made from living sult of the high cost of approval and price competition from manufacturers of reference drugs [5]. The Euro- pean Medicines Agency (EMA) has authorized the first * Correspondence: gabrielamosegui@uol.com.br biosimilar in over than10 years, and since then, there Department of Health and Society, Community Health Institute, Fluminense Federal University, Rua: Marquês do Paraná, 303, 3° floor, annex building, has been an intense debate about access, penetration Niterói, RJ CEP: 24033-900, Brazil with regard to originals and the prescription of these Full list of author information is available at the end of the article © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 2 of 7 products in European Union (EU) countries. There are Vigilância Sanitária (Anvisa), from Colombia - Instituto some factors that can influence the entry of biosimilars Nacional de Vigilância de Medicamentos y Alimentos into the markets of different countries, ranging from the (Invima), from Spain (Consejo General de Colegios Ofi- product itself, the therapeutic area to which the product ciales de Farmacéuticos) and from Mexico - Comisión is directed, the sanitary policy adopted, the price and Federal para la Protección contra Riesgos Sanitarios therefore the access, and finally the prescriptive stan- (Cofepris) [16–19]. RA treatment guides from each of dards [6]. these countries were reviewed and consulted in pursuit These supplies are among the top-selling drugs in the of other therapeutic possibilities that had not been cap- world market. In Brazil, in 2017, the revenues of com- tured to complement the registration data [2]. panies that marketed biopharmaceuticals was R$ 15,409, From the product lists launched between 1998 and 519,216 or US$ 491,707,322 [7]. Four of the twenty sub- 2019, 14 authorized in Spain and Brazil, 16 in the US, stances with the highest revenues this year in the Brazil- and 13 in Mexico and Colombia, a sample of 10 anti- ian market were biological, with three of them rheumatic biological drugs common to all these coun- (adalimumab, infliximab, and etanercept) used for RA tries was defined for the treatment of RA. These were [7]. All of these therapeutic options already have biosi- listed by authorization year, pharmaceutical form(s), and milars on the market [8–10]. In 2013, biosimilars similar packaging. Biosimilars authorized in this period accounted for approximately 25% of the total biological were also included. For these inputs, the date taken cor- sales, the patents of which having expired in the EU. In responded to when the first manufacturer registered the 2015, the biosimilar market amounted to US$ 490 mil- product by searching data information in Anvisa, Cofe- lion in the EU-5, Germany, Spain, France, Italy and the pris, Consejo General of Official Colleges of Pharmaceu- United Kingdom [6]. ticals and Invima, by year of publication and by According to Zozoya and González [11] some studies consulting the records [16–19]. The year of marketing have tried to estimate the economy magnitude produced authorization publication guided price monitoring. The with biosimilar introduction. In Spain, this saving was drug associations were excluded. The unit of analysis of between 300 and 2800 million euros between 2007 and the study was the product, considering the same concen- 2020. In Latin America, the regulation and penetration trations and packaging. of these drugs varies considerably [12], and most of the Price research was carried out on the official bases of available studies focus on the normative issue, not on each of these countries, except for the US. The values prices] [4, 12–15]. identified were the retail reference values for the year The importance of biosimilars in public health is re- 2019. In Brazil, the prices on the Anvisa website [20] lated to the costs of the original medicines and the were consulted. The standard set for Brazil was the max- demographic and epidemiological profiles of the popula- imum consumer price (MCP), which refers to 18% of tion. Their adoption can lead to considerable cost sav- the tax on the circulation of goods and services. In the ings [15]. It is crucial to the political debate to have US, market prices were captured from Drugs.com [21], concrete data on how the biosimilar market is evolving and in Spain, from Consejo General de Colegios Oficiales and how it will behave in the future, given the high de- de Farmacéuticos [19]. Colombian prices were obtained gree of innovation in the sector and the speed of incorp- from reference price listings from 2019 for the month/ oration of new technologies demanded by society and base September in the Digital Institutional Repository of health systems. The objective of this paper is to analyze the Ministry of Health [22]. In Mexico, reference prices the prices of biological drugs in the treatment of RA in for patented drugs were obtained from an official price three LA countries, namely, Brazil, Colombia and list [23]. Complementary consultation was made at the Mexico, as well as in Spain and the United States of Government-recommended site for 2019 only [24]. America (US), from the point of market entry of For products with different quantities of pharmaceut- biosimilars. ical units per package, for the same pharmaceutical form and concentration, the price of the package with the lar- Methods gest quantity or cheapest presentation was taken. Only The records and prices of biological products of the an- two drug samples differed in presentation and concen- tirheumatic class used in the treatment of RA, approved tration, and both were reduced to the smallest unit of from 1998 in Brazil, Colombia and Mexico, were ana- presentation for comparison. lyzed. An initial list of medicines for the treatment of All prices were converted to US dollars using the Cen- RA released annually in the US market by the Food and tral Bank of Brazil exchange rates [25]; the purchasing Drug Administration (FDA) has been created [9]. Regis- power or purchasing power parity (PPP) was used as an- tration information on these drugs has been taken from other price comparator. PPP conversion factor is a cur- Brazilian drug regulatory agencies - Agência Nacional de rency converter and spatial price deflator that controls Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 3 of 7 for price level differences between countries. PPP values FDA approved all these biosimilars, but only infliximab for 2019 were used, the latest available from the World is marketed. Adalimumab is authorized only in Spain, Bank [26, 27]. while etanercept and infliximab are approved in the This study did not require institutional review board three LA countries and in Spain. Rituximab is not in approval or informed consent, as it was based on public Invima, the Colombian registration system. data and did not involve patient records. There is no average difference between the release time in the US and that in other countries that deserves Results consideration as an indication of the greater “availability” The immunobiological drugs and biosimilar drugs an- of these inputs in one country or another. Marketing au- alyzed, which are simultaneously registered and ap- thorizations for biopharmaceuticals and biosimilars in pear in official lists as well as in the clinical protocols the US are from 2002. Although Spain, Brazil and of the 3 LA countries, are listed in the following Colombia have approved biological agents for RA since table. the 1990s, we concentrate on those from 2014, 2009 and The registered year of publication guided the price 2015, respectively; additionally, Mexico has approved monitoring developments in subsequent years. In the them since 2013. For biosimilars, Spain has adopted US, the FDA registered 13 distinct biologicals in the them since 2013, Brazil since 2014, Colombia since 2006 period and 4 biosimilars. Spain and Brazil recorded the and Mexico since 1999. 14 selected RA drugs in the period: 10 originals and 4 Table 1 shows the prices in US dollars and PPP of biosimilars. Colombia and Mexico registered 3 biosimi- medicines per package in the analyzed markets. lars in addition to 10 biologicals [9, 18, 20, 28]. Biosimi- The blank cells in Table 2 represent data not found in lars approved for commercialization include the queried databases. Regarding the prices of biological adalimumab, etanercept, infliximab and rituximab. The medicines used for RA, the US is the most expensive Table 1 Prices comparison of RA biological agents registered between 1998 and 2019 in Brazil, Colombia, Spain, United States (US) and Mexico, in US dollars (US$) per presentation and PPP. Source: [19–27] Drug Dosage forms (DF) US Spain PPP Brazil PPP Colombia PPP Mexico PPP (US$/ (US$/ Spain (US$/ Brazil (US$/DF) Colombia (US$/DF) Mexico DF) DF) DF) Abatacept 250 mg, injection powder 1167,3 447,2 636,5 450,2 812,5 324,4 823,8 431,8 902,5 Adalimumab 40 mg/0.8 mL (1 ea) 5411,3 1256,9 1788, 2729,0 4925, 796,4 2022,4 516,9 1080,5 9 6 Adalimumab 40 mg/0.8 mL (1 ea) 1256,9 1788, (biosimilar) 9 Baricitinib 2 mg tablets (30 tablets) 2240,4 1155,5 1644, 920,9 1662, 894,2 1869,0 4 0 Certolizumabe 200 mg in 1 mL, injection, kit 9054,7 1164,4 1657, 691,3 1247, 703,5 1786,7 1059,4 2214,4 pegol 1 7 Etanercept 50 mg/mL (0.98 mL, 1 mL), Solution 5411,2 848,7 1207, 1255,1 2265, 831,2 2110,8 1188,1 2483,4 Prefilled Syringe, Subcutaneous 9 3 Etanercept 50 mg/mL (0.98 mL, 1 mL), Solution 848,7 1207, 899,1 1622, 415,6 1055,4 (biosimilar) Prefilled Syringe, Subcutaneous 9 7 Golimumab 50 mg/0.5 mL (0.5 mL) 5030,1 1359,6 1934, 1316,6 2376, 829,4 2106,3 1298,2 2713,4 9 2 Infliximab 100 mg (1 ea) 1228, 687,0 977,8 1365,5 2464, 390,2 990,9 713,1 1490,4 70 7 Infliximab 100 mg (1 ea) 997,4 568,8 809,5 862,8 1557, 400,4 836,8 (biosimilar) 3 Rituximab 10 mg/mL (10 mL) 1998,7 633,5 901,6 673,9 1216, 451,9 1147,6 865,9 1809,9 Rituximab 10 mg/mL (10 mL) 546,5 777,8 404,9 730,7 (biosimilar) Tocilizumab 20 mg/4 mL (4 mL), Solution, 476,9 215,3 306,3 165,8 299,3 97,2 246,9 192,6 402,6 Intravenous Tofacitinib 5 mg tablets (60 tablets) 4687,3 1020,5 1452, 1893,2 3417, 810,2 2057,5 940,3 1965,3 4 1 Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 4 of 7 Table 2 Innovative and biosimilar drugs used to treat rheumatoid arthritis (RA), approved from 1998 to 2019, in the countries analyzed Drugs Registration year Country Abatacept 2005 US 2007 Brazil 2012 Spain 2016 Mexico 2018 Colombia Adalimumab 2002 US 2003 Brazil/Colombia 2010 Mexico 2018 Spain Adalimumab 2018 Spain Biosimilar 2019 Brazil/Colombia 2015 US Baricitinib 2017 Spain/Mexico 2018 US/Brazil 2019 Colombia Certolizumabe pegol 2009 US 2011 Brazil 2016 Colombia 2017 Spain/Mexico Etanercept 1999 Mexico 2002 US 2003 Brazil 2006 Spain 2007 Colombia Etanercept biosimilar 2006 Colombia 2013 Brazil/Mexico 2016 US 2017 Spain Golimumab 2009 US 2011 Brazil/Colombia 2013 Spain 2014 Mexico Infliximab 1999 Spain 2000 Colombia 2001 US 2007 Brazil 2016 Mexico Infliximab 2014 Spain/Mexico Biosimilar 2013 US 2015 Brazil 2017 Colombia Rituximab 1998 Brazil/Spain 1999 Colombia Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 5 of 7 Table 2 Innovative and biosimilar drugs used to treat rheumatoid arthritis (RA), approved from 1998 to 2019, in the countries analyzed (Continued) Drugs Registration year Country 2006 US 2017 Mexico Rituximab 2017 Spain/Mexico Biosimilar 2019 Brazil Tocilizumab 2009 Brazil/Mexico 2010 US 2014 Spain 2015 Colombia Tofacitinib 2012 US 2013 Mexico 2014 Brazil 2018 Colombia/Spain country. Spain’s price behavior seems intermediate when Discussion compared to the three LA countries. Brazil has the high- The main objective of this study was to analyze the evo- est LA prices, followed by Mexico and Colombia, which lution of the prices of biosimilar medicines in three LA have the lowest prices. When comparing US prices to countries, Spain and the US. Prices between countries Spanish prices in dollars, Spain has lower priced drugs. were also compared on the basis of the PPP, which links For biosimilars, adalimumab is marketed only in Spain drug values to differences in purchasing power levels. and has the same value as the original drug (US$ Our study points to a much lower affordability for the 1256.9). The biosimilar etanercept has the same price as citizens of LA countries (as their prices, corrected by the its original in Spain (US$ 848.7) but is cheaper in Brazil PPP, were higher than in Spain, a wealthier country). and Colombia than the innovative drug (by 28.4 and This trend of the acquisition effort is not repeated in the 50%, respectively). This biosimilar is, in turn, more ex- United States, which has the highest PPP among the 5 pensive in both LA countries than in Spain. Infliximab is countries. Putrik and collaborators [29] investigated the the only biosimilar of this class marketed in the US and availability, accessibility and acceptability for synthetic has a difference of minus 18.8% from the value of the and biological drugs in European countries, relating original product. Spain, Brazil and Mexico also have them to the socioeconomic status, well-being and health lower prices for this biosimilar (17.2; 36.8; and 43.9%, re- status of patients with RA. The prices of biological drugs spectively) than that of the innovative drug. Only Spain for RA differed by up to 7.3 and 1.3 times, respectively, and Brazil trade the biosimilar rituximab, with prices up after adjusting for the PPP, between countries. to approximately 40% cheaper than that of the original. The findings of this paper should be carefully inter- Prices were also correlated between countries, based on preted. For the price analysis of medicines, international the PPP, when considering that the purchasing capacity comparisons should be cautious, as wholesale prices may changes compared to prices previously analyzed. Still under produce misleading information [30]. Biological agents this interpretation, the US, which exhibited higher prices are only one drug class among many existing in the ana- for biological drugs for the treatment of RA, maintains the lyzed countries. We tried to compare the prices of drugs highest PPP values, all higher than those of Spain and the that coincided with each other in presentation, concen- LA countries, except for infliximab in Brazil and Mexico. tration, formulation, and manufacturer, but the periods The PPP for Spain is lower than that of the Latin American in which they were available on the market are different. countries, except for adalimumab in Mexico, tocilizumab in An ideal price analysis would control all these features. Brazil and Colombia, biosimilar rituximab in Brazil and bio- Sales data on these inputs would be important. The use similar etanercept in Colombia. The PPP values of Brazil of official databases, rather observing their structure, are similar to those of Mexico, considering the absolute with information gaps that limit the progress of evalua- and relative number of medicines in each of these coun- tions from these data, should be evaluated. There is a tries. Colombia’s PPP values are lower than in Mexico and loss in the comparison between the PPP of the LA coun- Brazil. The three LA countries have PPP values higher than tries given the heterogeneity of the markets and inaccur- those of Spain and lower than US drug prices. acy in the data depicted. Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 6 of 7 In addition to the great potential of the data available systems in emerging countries, where potential cost sav- for health services, there is the scarcity of studies of this ings are highly valued. type and the complexity of exploring background infor- The PPP strategy ensured a better understanding of mation with so many particularities and differences. access to biological products for RA. The economic ef- Recent registration approvals, nonmarketing of the fort of the United States and Spain is much less than product or even the absence of distributors may be be- that of these LA countries. Although the price of some hind the absence of a drug in the market. These trends, of these drugs is lower in LA countries, the effort to ob- registration approval characteristics, and the marketing tain them is much higher and the differences noted are itself provide important information for prescribers, pa- greater when converted into PPP units. Tracking the tients, and the industry [31]. None of the drugs analyzed prices of these drugs as patents are lost can be a way to appear in the Mexican government’s price comparison avoid monopolies. One step has already been taken re- [32]. In Mexico, biosimilar approvals were found prior garding health regulation; other larger ones should take to those of the original products, somewhat illustrating place regarding pricing and agreements with the the lack of clarity of the database [16]. Marketing ap- pharmaceutical industry. proval for unregistered but sale-authorized biological Acknowledgements agents in the European Union, the US, Canada, and Carolina Foundation and Tordesillas Group for GBGM three months Australia can be obtained in the respective countries scholarship. [28]. Differences in legislation and database updating or Conflict of interest completion may explain the different approval dates of none, stated by the authors. biologics as approved biosimilars before their originals. Declaration In Colombia, Bernal-Camargo and collaborators [13] The opinions expressed in this manuscript are those of the authors and do point to problems in the classification of Invima- not necessarily reflect HER’s criteria or policy. registered biosimilars, which, due to legal, information, Authors’ contributions availability and access barriers, make informed con- GBGM had substantial contributions to the conception and design of the sumption difficult for the population. work, analysis and interpretation of data, draft the paper and revised it. FA Some biosimilar products, although approved for the had substantial contributions to the conception and design of the work, interpretation of data and revision of the final manuscript. CMMV had US market, are not sold. These are licensing agreements contribute with the analysis and interpretation of data and revision of the with the original manufacturer that would allow the bio- final manuscript. PR had contribute with the analysis and interpretation of similar to be launched later, up to 5 litigations, such as data and revision of the final manuscript. We agreed both to be personally accountable for the author’s own one of etanercept’s biosimilars [33]. contributions and to ensure that questions related to the accuracy or The high prices for medicines in the American market integrity of any part of the work, even ones in which the author was not are not new. Mexico and Colombia may have lower personally involved, are appropriately investigated, resolved, and the resolution documented in the literature. prices than those in Brazil due to differences in input All authors read and approved the final manuscript as they have approved costs, tariff barriers, taxes, market power, industry regu- the submitted version. lation, healthcare systems or consumer preferences [34]. Funding The economic impact of biosimilars on sanitary sys- GBGM received a three-month fellowship for a postdoctoral office in Log- tems can be achieved through direct savings associated roño (Spain) during the preparation of this study by the Carolina Foundation with lower prices. By competing with the original prod- in collaboration with the Tordesillas Group. ucts, they eventually bring down the price of biological Availability of data and materials medicines [35]. According to Zozaya, and Gonzalez [11], All data generated or analyzed during this study are included in this the price difference between a biosimilar and its original published article. ranges from 6 to 37% in Europe. In addition, discounts Ethics approval and consent to participate on purchases often apply. In Spain, where the price of Not applicable. reference biologicals should equal the lowest price of their biosimilar counterparts, average discounts are 20% Consent for publication Not applicable. [6, 35].. Competing interests Conclusions None. The study compared biosimilar and biological drug Author details prices and registration times for RA. Biosimilar market 1 Department of Health and Society, Community Health Institute, Fluminense penetration of these RA drugs differs greatly from coun- Federal University, Rua: Marquês do Paraná, 303, 3° floor, annex building, Niterói, RJ CEP: 24033-900, Brazil. Department of Economy and Company, try to country, varying even within the commercialized Economy Faculty, University of La Rioja, Calle la Cigüeña, 60, 26006 Logroño, therapeutic classes. The use of biosimilars may increase 3 La Rioja, Spain. Department of Health Policy, Planning and Management, the viability of treatment of many patients in health care Health Medicine Institute, Rio de Janeiro Estadual University, Rua São Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 7 of 7 Francisco Xavier 524 – Maracanã, Bloco D, 7° floor, Rio de Janeiro, RJ 18. 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Springer Nature remains neutral with regard to jurisdictional claims in Desenvolvimento de biossimilares no Brasil. Fronteiras. 2016;5(1):31–42. published maps and institutional affiliations. 16. Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris). Listados de Registros Sanitarios de Medicamentos . Governo do México. 2019 [access 2019 Nov 1]. Available from: https://www.gob.mx/cofepris/ documentos/registros-sanitarios-medicamentos 17. Agência Nacional de Vigilância Sanitária (Anvisa). Consulta ao registro de medicamentos . 2019 [access 2019 Nov 1]. Available from: http://portal.a nvisa.gov.br/consulta-produtos-registrados http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Advances in Rheumatology Springer Journals

Drug prices in Latin American countries: the case of rheumatoid arthritis Biosimilars

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Abstract

Background: The objective of this paper is to analyze the prices of biological drugs in the treatment of Rheumatoid Arthritis (RA) in three Latin American countries (Brazil, Colombia and Mexico), as well as in Spain and the United States of America (US), from the point of market entry of biosimilars. Methods: We analyzed products authorized for commercialization in the last 20 years, in Brazil, Colombia, and Mexico, comparing them to the United States of America (USA) and Spain. For this analysis, we sought the prices and registries of drugs marketed between 1999 and October 1, 2019, in the regulatory agencies’ databases. The pricing between countries was based on purchasing power parity (PPP). Results: The US authorized the commercialization of 13 distinct biologicals and four biosimilars in the period. Spain and Brazil marketed 14 biopharmaceuticals for RA, ten original, four biosimilars. Colombia and Mexico have authorized three biosimilars in addition to the ten biological ones. For biological drug prices, the US is the most expensive country. Spain’s price behavior seems intermediate when compared to the three LA countries. Brazil has the highest LA prices, followed by Mexico and Colombia, which has the lowest prices. Spain has the lowest values in PPP, compared to LA countries, while the US has the highest prices. Conclusion: The economic effort that LA countries make to access these medicines is much higher than the US and Spain. The use of the PPP ensured a better understanding of the actual access to these inputs in the countries analyzed. Keywords: Biological products, Antirheumatic agents, Access to essential medicines and health technologies, Products registration, Drug Price Introduction cells whose development is longer and more costly than Rheumatoid arthritis (RA) is a chronic inflammatory that of traditional products. The economic risks involved autoimmune disease that affects 0.3 to 1.0% of the world in this process are high. There is no difference in obtain- population. This prevalence seems to be lower in emer- ing a biosimilar drug, where companies assume the same ging countries, given the differences in age distribution strategic level as those who hold the patents or creators among population groups, difficulty in accessing the of the original biopharmaceutical [3]. Biosimilars are not health system, lack of diagnosis and lack of studies [1]. generic drugs and may differ from reference products in Biological agents used to treat moderate or severe ac- manufacturing, composition and formulation [4]. tive disease reduce inflammation and prevent joint dam- In the US market, few biosimilars are available as a re- age [2]. These are innovative products made from living sult of the high cost of approval and price competition from manufacturers of reference drugs [5]. The Euro- pean Medicines Agency (EMA) has authorized the first * Correspondence: gabrielamosegui@uol.com.br biosimilar in over than10 years, and since then, there Department of Health and Society, Community Health Institute, Fluminense Federal University, Rua: Marquês do Paraná, 303, 3° floor, annex building, has been an intense debate about access, penetration Niterói, RJ CEP: 24033-900, Brazil with regard to originals and the prescription of these Full list of author information is available at the end of the article © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 2 of 7 products in European Union (EU) countries. There are Vigilância Sanitária (Anvisa), from Colombia - Instituto some factors that can influence the entry of biosimilars Nacional de Vigilância de Medicamentos y Alimentos into the markets of different countries, ranging from the (Invima), from Spain (Consejo General de Colegios Ofi- product itself, the therapeutic area to which the product ciales de Farmacéuticos) and from Mexico - Comisión is directed, the sanitary policy adopted, the price and Federal para la Protección contra Riesgos Sanitarios therefore the access, and finally the prescriptive stan- (Cofepris) [16–19]. RA treatment guides from each of dards [6]. these countries were reviewed and consulted in pursuit These supplies are among the top-selling drugs in the of other therapeutic possibilities that had not been cap- world market. In Brazil, in 2017, the revenues of com- tured to complement the registration data [2]. panies that marketed biopharmaceuticals was R$ 15,409, From the product lists launched between 1998 and 519,216 or US$ 491,707,322 [7]. Four of the twenty sub- 2019, 14 authorized in Spain and Brazil, 16 in the US, stances with the highest revenues this year in the Brazil- and 13 in Mexico and Colombia, a sample of 10 anti- ian market were biological, with three of them rheumatic biological drugs common to all these coun- (adalimumab, infliximab, and etanercept) used for RA tries was defined for the treatment of RA. These were [7]. All of these therapeutic options already have biosi- listed by authorization year, pharmaceutical form(s), and milars on the market [8–10]. In 2013, biosimilars similar packaging. Biosimilars authorized in this period accounted for approximately 25% of the total biological were also included. For these inputs, the date taken cor- sales, the patents of which having expired in the EU. In responded to when the first manufacturer registered the 2015, the biosimilar market amounted to US$ 490 mil- product by searching data information in Anvisa, Cofe- lion in the EU-5, Germany, Spain, France, Italy and the pris, Consejo General of Official Colleges of Pharmaceu- United Kingdom [6]. ticals and Invima, by year of publication and by According to Zozoya and González [11] some studies consulting the records [16–19]. The year of marketing have tried to estimate the economy magnitude produced authorization publication guided price monitoring. The with biosimilar introduction. In Spain, this saving was drug associations were excluded. The unit of analysis of between 300 and 2800 million euros between 2007 and the study was the product, considering the same concen- 2020. In Latin America, the regulation and penetration trations and packaging. of these drugs varies considerably [12], and most of the Price research was carried out on the official bases of available studies focus on the normative issue, not on each of these countries, except for the US. The values prices] [4, 12–15]. identified were the retail reference values for the year The importance of biosimilars in public health is re- 2019. In Brazil, the prices on the Anvisa website [20] lated to the costs of the original medicines and the were consulted. The standard set for Brazil was the max- demographic and epidemiological profiles of the popula- imum consumer price (MCP), which refers to 18% of tion. Their adoption can lead to considerable cost sav- the tax on the circulation of goods and services. In the ings [15]. It is crucial to the political debate to have US, market prices were captured from Drugs.com [21], concrete data on how the biosimilar market is evolving and in Spain, from Consejo General de Colegios Oficiales and how it will behave in the future, given the high de- de Farmacéuticos [19]. Colombian prices were obtained gree of innovation in the sector and the speed of incorp- from reference price listings from 2019 for the month/ oration of new technologies demanded by society and base September in the Digital Institutional Repository of health systems. The objective of this paper is to analyze the Ministry of Health [22]. In Mexico, reference prices the prices of biological drugs in the treatment of RA in for patented drugs were obtained from an official price three LA countries, namely, Brazil, Colombia and list [23]. Complementary consultation was made at the Mexico, as well as in Spain and the United States of Government-recommended site for 2019 only [24]. America (US), from the point of market entry of For products with different quantities of pharmaceut- biosimilars. ical units per package, for the same pharmaceutical form and concentration, the price of the package with the lar- Methods gest quantity or cheapest presentation was taken. Only The records and prices of biological products of the an- two drug samples differed in presentation and concen- tirheumatic class used in the treatment of RA, approved tration, and both were reduced to the smallest unit of from 1998 in Brazil, Colombia and Mexico, were ana- presentation for comparison. lyzed. An initial list of medicines for the treatment of All prices were converted to US dollars using the Cen- RA released annually in the US market by the Food and tral Bank of Brazil exchange rates [25]; the purchasing Drug Administration (FDA) has been created [9]. Regis- power or purchasing power parity (PPP) was used as an- tration information on these drugs has been taken from other price comparator. PPP conversion factor is a cur- Brazilian drug regulatory agencies - Agência Nacional de rency converter and spatial price deflator that controls Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 3 of 7 for price level differences between countries. PPP values FDA approved all these biosimilars, but only infliximab for 2019 were used, the latest available from the World is marketed. Adalimumab is authorized only in Spain, Bank [26, 27]. while etanercept and infliximab are approved in the This study did not require institutional review board three LA countries and in Spain. Rituximab is not in approval or informed consent, as it was based on public Invima, the Colombian registration system. data and did not involve patient records. There is no average difference between the release time in the US and that in other countries that deserves Results consideration as an indication of the greater “availability” The immunobiological drugs and biosimilar drugs an- of these inputs in one country or another. Marketing au- alyzed, which are simultaneously registered and ap- thorizations for biopharmaceuticals and biosimilars in pear in official lists as well as in the clinical protocols the US are from 2002. Although Spain, Brazil and of the 3 LA countries, are listed in the following Colombia have approved biological agents for RA since table. the 1990s, we concentrate on those from 2014, 2009 and The registered year of publication guided the price 2015, respectively; additionally, Mexico has approved monitoring developments in subsequent years. In the them since 2013. For biosimilars, Spain has adopted US, the FDA registered 13 distinct biologicals in the them since 2013, Brazil since 2014, Colombia since 2006 period and 4 biosimilars. Spain and Brazil recorded the and Mexico since 1999. 14 selected RA drugs in the period: 10 originals and 4 Table 1 shows the prices in US dollars and PPP of biosimilars. Colombia and Mexico registered 3 biosimi- medicines per package in the analyzed markets. lars in addition to 10 biologicals [9, 18, 20, 28]. Biosimi- The blank cells in Table 2 represent data not found in lars approved for commercialization include the queried databases. Regarding the prices of biological adalimumab, etanercept, infliximab and rituximab. The medicines used for RA, the US is the most expensive Table 1 Prices comparison of RA biological agents registered between 1998 and 2019 in Brazil, Colombia, Spain, United States (US) and Mexico, in US dollars (US$) per presentation and PPP. Source: [19–27] Drug Dosage forms (DF) US Spain PPP Brazil PPP Colombia PPP Mexico PPP (US$/ (US$/ Spain (US$/ Brazil (US$/DF) Colombia (US$/DF) Mexico DF) DF) DF) Abatacept 250 mg, injection powder 1167,3 447,2 636,5 450,2 812,5 324,4 823,8 431,8 902,5 Adalimumab 40 mg/0.8 mL (1 ea) 5411,3 1256,9 1788, 2729,0 4925, 796,4 2022,4 516,9 1080,5 9 6 Adalimumab 40 mg/0.8 mL (1 ea) 1256,9 1788, (biosimilar) 9 Baricitinib 2 mg tablets (30 tablets) 2240,4 1155,5 1644, 920,9 1662, 894,2 1869,0 4 0 Certolizumabe 200 mg in 1 mL, injection, kit 9054,7 1164,4 1657, 691,3 1247, 703,5 1786,7 1059,4 2214,4 pegol 1 7 Etanercept 50 mg/mL (0.98 mL, 1 mL), Solution 5411,2 848,7 1207, 1255,1 2265, 831,2 2110,8 1188,1 2483,4 Prefilled Syringe, Subcutaneous 9 3 Etanercept 50 mg/mL (0.98 mL, 1 mL), Solution 848,7 1207, 899,1 1622, 415,6 1055,4 (biosimilar) Prefilled Syringe, Subcutaneous 9 7 Golimumab 50 mg/0.5 mL (0.5 mL) 5030,1 1359,6 1934, 1316,6 2376, 829,4 2106,3 1298,2 2713,4 9 2 Infliximab 100 mg (1 ea) 1228, 687,0 977,8 1365,5 2464, 390,2 990,9 713,1 1490,4 70 7 Infliximab 100 mg (1 ea) 997,4 568,8 809,5 862,8 1557, 400,4 836,8 (biosimilar) 3 Rituximab 10 mg/mL (10 mL) 1998,7 633,5 901,6 673,9 1216, 451,9 1147,6 865,9 1809,9 Rituximab 10 mg/mL (10 mL) 546,5 777,8 404,9 730,7 (biosimilar) Tocilizumab 20 mg/4 mL (4 mL), Solution, 476,9 215,3 306,3 165,8 299,3 97,2 246,9 192,6 402,6 Intravenous Tofacitinib 5 mg tablets (60 tablets) 4687,3 1020,5 1452, 1893,2 3417, 810,2 2057,5 940,3 1965,3 4 1 Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 4 of 7 Table 2 Innovative and biosimilar drugs used to treat rheumatoid arthritis (RA), approved from 1998 to 2019, in the countries analyzed Drugs Registration year Country Abatacept 2005 US 2007 Brazil 2012 Spain 2016 Mexico 2018 Colombia Adalimumab 2002 US 2003 Brazil/Colombia 2010 Mexico 2018 Spain Adalimumab 2018 Spain Biosimilar 2019 Brazil/Colombia 2015 US Baricitinib 2017 Spain/Mexico 2018 US/Brazil 2019 Colombia Certolizumabe pegol 2009 US 2011 Brazil 2016 Colombia 2017 Spain/Mexico Etanercept 1999 Mexico 2002 US 2003 Brazil 2006 Spain 2007 Colombia Etanercept biosimilar 2006 Colombia 2013 Brazil/Mexico 2016 US 2017 Spain Golimumab 2009 US 2011 Brazil/Colombia 2013 Spain 2014 Mexico Infliximab 1999 Spain 2000 Colombia 2001 US 2007 Brazil 2016 Mexico Infliximab 2014 Spain/Mexico Biosimilar 2013 US 2015 Brazil 2017 Colombia Rituximab 1998 Brazil/Spain 1999 Colombia Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 5 of 7 Table 2 Innovative and biosimilar drugs used to treat rheumatoid arthritis (RA), approved from 1998 to 2019, in the countries analyzed (Continued) Drugs Registration year Country 2006 US 2017 Mexico Rituximab 2017 Spain/Mexico Biosimilar 2019 Brazil Tocilizumab 2009 Brazil/Mexico 2010 US 2014 Spain 2015 Colombia Tofacitinib 2012 US 2013 Mexico 2014 Brazil 2018 Colombia/Spain country. Spain’s price behavior seems intermediate when Discussion compared to the three LA countries. Brazil has the high- The main objective of this study was to analyze the evo- est LA prices, followed by Mexico and Colombia, which lution of the prices of biosimilar medicines in three LA have the lowest prices. When comparing US prices to countries, Spain and the US. Prices between countries Spanish prices in dollars, Spain has lower priced drugs. were also compared on the basis of the PPP, which links For biosimilars, adalimumab is marketed only in Spain drug values to differences in purchasing power levels. and has the same value as the original drug (US$ Our study points to a much lower affordability for the 1256.9). The biosimilar etanercept has the same price as citizens of LA countries (as their prices, corrected by the its original in Spain (US$ 848.7) but is cheaper in Brazil PPP, were higher than in Spain, a wealthier country). and Colombia than the innovative drug (by 28.4 and This trend of the acquisition effort is not repeated in the 50%, respectively). This biosimilar is, in turn, more ex- United States, which has the highest PPP among the 5 pensive in both LA countries than in Spain. Infliximab is countries. Putrik and collaborators [29] investigated the the only biosimilar of this class marketed in the US and availability, accessibility and acceptability for synthetic has a difference of minus 18.8% from the value of the and biological drugs in European countries, relating original product. Spain, Brazil and Mexico also have them to the socioeconomic status, well-being and health lower prices for this biosimilar (17.2; 36.8; and 43.9%, re- status of patients with RA. The prices of biological drugs spectively) than that of the innovative drug. Only Spain for RA differed by up to 7.3 and 1.3 times, respectively, and Brazil trade the biosimilar rituximab, with prices up after adjusting for the PPP, between countries. to approximately 40% cheaper than that of the original. The findings of this paper should be carefully inter- Prices were also correlated between countries, based on preted. For the price analysis of medicines, international the PPP, when considering that the purchasing capacity comparisons should be cautious, as wholesale prices may changes compared to prices previously analyzed. Still under produce misleading information [30]. Biological agents this interpretation, the US, which exhibited higher prices are only one drug class among many existing in the ana- for biological drugs for the treatment of RA, maintains the lyzed countries. We tried to compare the prices of drugs highest PPP values, all higher than those of Spain and the that coincided with each other in presentation, concen- LA countries, except for infliximab in Brazil and Mexico. tration, formulation, and manufacturer, but the periods The PPP for Spain is lower than that of the Latin American in which they were available on the market are different. countries, except for adalimumab in Mexico, tocilizumab in An ideal price analysis would control all these features. Brazil and Colombia, biosimilar rituximab in Brazil and bio- Sales data on these inputs would be important. The use similar etanercept in Colombia. The PPP values of Brazil of official databases, rather observing their structure, are similar to those of Mexico, considering the absolute with information gaps that limit the progress of evalua- and relative number of medicines in each of these coun- tions from these data, should be evaluated. There is a tries. Colombia’s PPP values are lower than in Mexico and loss in the comparison between the PPP of the LA coun- Brazil. The three LA countries have PPP values higher than tries given the heterogeneity of the markets and inaccur- those of Spain and lower than US drug prices. acy in the data depicted. Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 6 of 7 In addition to the great potential of the data available systems in emerging countries, where potential cost sav- for health services, there is the scarcity of studies of this ings are highly valued. type and the complexity of exploring background infor- The PPP strategy ensured a better understanding of mation with so many particularities and differences. access to biological products for RA. The economic ef- Recent registration approvals, nonmarketing of the fort of the United States and Spain is much less than product or even the absence of distributors may be be- that of these LA countries. Although the price of some hind the absence of a drug in the market. These trends, of these drugs is lower in LA countries, the effort to ob- registration approval characteristics, and the marketing tain them is much higher and the differences noted are itself provide important information for prescribers, pa- greater when converted into PPP units. Tracking the tients, and the industry [31]. None of the drugs analyzed prices of these drugs as patents are lost can be a way to appear in the Mexican government’s price comparison avoid monopolies. One step has already been taken re- [32]. In Mexico, biosimilar approvals were found prior garding health regulation; other larger ones should take to those of the original products, somewhat illustrating place regarding pricing and agreements with the the lack of clarity of the database [16]. Marketing ap- pharmaceutical industry. proval for unregistered but sale-authorized biological Acknowledgements agents in the European Union, the US, Canada, and Carolina Foundation and Tordesillas Group for GBGM three months Australia can be obtained in the respective countries scholarship. [28]. Differences in legislation and database updating or Conflict of interest completion may explain the different approval dates of none, stated by the authors. biologics as approved biosimilars before their originals. Declaration In Colombia, Bernal-Camargo and collaborators [13] The opinions expressed in this manuscript are those of the authors and do point to problems in the classification of Invima- not necessarily reflect HER’s criteria or policy. registered biosimilars, which, due to legal, information, Authors’ contributions availability and access barriers, make informed con- GBGM had substantial contributions to the conception and design of the sumption difficult for the population. work, analysis and interpretation of data, draft the paper and revised it. FA Some biosimilar products, although approved for the had substantial contributions to the conception and design of the work, interpretation of data and revision of the final manuscript. CMMV had US market, are not sold. These are licensing agreements contribute with the analysis and interpretation of data and revision of the with the original manufacturer that would allow the bio- final manuscript. PR had contribute with the analysis and interpretation of similar to be launched later, up to 5 litigations, such as data and revision of the final manuscript. We agreed both to be personally accountable for the author’s own one of etanercept’s biosimilars [33]. contributions and to ensure that questions related to the accuracy or The high prices for medicines in the American market integrity of any part of the work, even ones in which the author was not are not new. Mexico and Colombia may have lower personally involved, are appropriately investigated, resolved, and the resolution documented in the literature. prices than those in Brazil due to differences in input All authors read and approved the final manuscript as they have approved costs, tariff barriers, taxes, market power, industry regu- the submitted version. lation, healthcare systems or consumer preferences [34]. Funding The economic impact of biosimilars on sanitary sys- GBGM received a three-month fellowship for a postdoctoral office in Log- tems can be achieved through direct savings associated roño (Spain) during the preparation of this study by the Carolina Foundation with lower prices. By competing with the original prod- in collaboration with the Tordesillas Group. ucts, they eventually bring down the price of biological Availability of data and materials medicines [35]. According to Zozaya, and Gonzalez [11], All data generated or analyzed during this study are included in this the price difference between a biosimilar and its original published article. ranges from 6 to 37% in Europe. In addition, discounts Ethics approval and consent to participate on purchases often apply. In Spain, where the price of Not applicable. reference biologicals should equal the lowest price of their biosimilar counterparts, average discounts are 20% Consent for publication Not applicable. [6, 35].. Competing interests Conclusions None. The study compared biosimilar and biological drug Author details prices and registration times for RA. Biosimilar market 1 Department of Health and Society, Community Health Institute, Fluminense penetration of these RA drugs differs greatly from coun- Federal University, Rua: Marquês do Paraná, 303, 3° floor, annex building, Niterói, RJ CEP: 24033-900, Brazil. Department of Economy and Company, try to country, varying even within the commercialized Economy Faculty, University of La Rioja, Calle la Cigüeña, 60, 26006 Logroño, therapeutic classes. The use of biosimilars may increase 3 La Rioja, Spain. Department of Health Policy, Planning and Management, the viability of treatment of many patients in health care Health Medicine Institute, Rio de Janeiro Estadual University, Rua São Mosegui et al. Advances in Rheumatology (2021) 61:14 Page 7 of 7 Francisco Xavier 524 – Maracanã, Bloco D, 7° floor, Rio de Janeiro, RJ 18. 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Journal

Advances in Rheumatology – Springer Journals

Published: Feb 25, 2021

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