Rheumatoid arthritis (RA) is a disorder affecting the joints causing pain and stiffness. It is an increasingly common condition, with an estimated 24.5 million people worldwide living with the condition, according to 2015 data.

As an autoimmune and inflammatory disorder, RA can benefit from treatment with biological drugs targeting the inflammatory molecule tumour necrosis factor (TNF). Indeed, some of the most successful treatments for RA, such as adalimumab, etanercept and infliximab, target TNF.

However, biological treatments can be extremely expensive and therefore access to them remains limited. Biosimilar versions of these treatments are being developed in order to increase access, however, the effect of biosimilar market entry on prices and access to treatments around the world remains unclear.

In this study [1], researchers analysed the prices of biological drugs for RA in Latin America. The researchers focused on Brazil, Colombia and Mexico, as compared with Spain and the US.

They analysed the prices of biological products used in the treatment of RA in these countries between 1999 and 2019. This was based on registration information on the drugs from the relevant regulatory agencies and treatment guides from each of the countries. Biosimilars were included in the analysis. Of the Latin American countries, Mexico was the first to adopt off-patent biologicals (in 1999), followed by Colombia (2006) and Brazil (2014).

Price research was carried out, with all prices being converted to USD and purchasing power parity (PPP) being used as an additional price comparator which controls for differences in purchasing power levels. PPP values for 2019 were sourced from the World Bank.

The authors identified 17 biologicals (including four biosimilars) approved in the US in this period, compared to 14 in Spain and Brazil (also including four biosimilars). Colombia and Mexico registered 13 biologicals during the period, of which three were biosimilars. The biosimilars included in the study were adalimumab, etanercept, infliximab and rituximab. In the US, only infliximab is marketed, while etanercept and infliximab are approved in the three Latin American countries and in Spain. Adalimumab is only authorized in Spain. Rituximab is not authorized in Colombia.

Price analysis found drug prices to be overall highest in the US. For Latin America, prices were highest in Brazil followed by Mexico and Colombia. Price analysis focused on biosimilars showed that in Spain, the only country in the study where adalimumab is authorized, adalimumab has the same value as the originator (US$1,257). Likewise in Spain, etanercept has the same value as its originator (US$849), while in Brazil and Colombia it is 28% and 50% cheaper, respectively. Despite this, etanercept is still more expensive in these countries than it is in Spain.

In the US, infliximab was the only biosimilar for sale and was found to be 18.8% cheaper than its originator. In Mexico, infliximab is 43.9% cheaper than its originator, compared with 36.8% in Brazil and 17.2% in Spain. Biosimilar rituximab, which is sold in Brazil and Spain, was found to be 40% cheaper than its originator.

When using PPP, which compares prices between countries considering purchasing capacity differences, the US remained the most expensive country for RA biologicals. The PPP for Spain was on average lower than that of the Latin American countries. The PPP values of Brazil were similar to those of Mexico, while Colombia’s PPP values were lower than in Mexico and Brazil. Lower prices in Colombia may be due to differences in input costs, tariffs, taxes, market power, regulation, healthcare systems and consumer preferences, the authors suggest.

The authors conclude that RA biological drugs are less affordable in Latin America than in Spain, however, biologicals remain most unaffordable in the US, which had the highest PPP of the countries analyzed.

They also say that the Latin American countries studied make greater economic efforts to obtain these drugs than the US or Spain, although their price may be lower. As more patents on biological drugs expire, the authors call for greater regulatory efforts in order to prevent monopolies developing in the pharmaceutical industry.

Conflict of interest statement
The authors of the research paper [1] declared no competing interests.

Editor’s comment
Readers interested to learn more about biosimilars in Latin America are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Current trends for biosimilars in the Latin American market

Online biosimilars resource for patients across Latin America

New monoclonal antibody biosimilars approved in 2015 in Latin America: position statement of the Latin American Forum on Biosimilars on biosimilarity, interchangeability and extrapolation of indications

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Reference
1. Mosegui G, Antõnanzas F, de Mello Vianna C, et al. 2021. Drug prices in Latin American countries: the case of rheumatoid arthritis biosimilars. Adv Rheumatol. 2021;61(1):14.

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