Abstract

ObjectiveTo compare the market dynamics of biosimilar infliximab among four Organization for Economic Cooperation and Development (OECD) countries (UK, France, Japan, and Korea) where supply-side and demand-side policies varied greatly, given high and growing expenditure on biological medicines to treat immunological diseases across countries.MethodsA quarterly dataset covering October 2012 to March 2018 was constructed from the MIDAS-IQVIA International database. The sales value (in USD) and volume (in standard units) of originator infliximab and biosimilar products and their relative price in each country were compared.ResultsWith the introduction of biosimilars, the sales value of infliximab increased approximately 2.5 times in Korea, whereas it only slightly increased (1.2 times for France and the UK) or decreased (0.9 for Japan) in other countries. While stable market size dynamics were observed in the other countries, an escalating market size, attributable to the increase in originator infliximab, was observed in Korea. In the UK and France, which have implemented demand-side policies, the sales volume of originator infliximab appreciably decreased after the entry of biosimilar infliximab while that of biosimilars increased; however, in Korea, which has supply-side policies based on price-linking with few demand-side policies, the volume of originator infliximab actually increased by 70% alongside a very limited increase in biosimilar infliximab. The lowest price ratio between biosimilar and originator infliximab was found in Japan, at 68%. In France and Korea, the ex-factory prices of biosimilar infliximab were 99 and 95%, respectively, of the originator infliximab price. In the UK, the ex-factory price of biosimilar infliximab started at 87% of that of originator infliximab and then decreased to 80% as the market matured. However, actual price differences might differ.ConclusionThe uptake of biosimilar infliximab varied greatly, and in contrast to the UK, France, and Japan, the introduction of biosimilar infliximab resulted in market expansion in Korea, which might be explained by a lack of demand-side policies in Korea. Both supply- and demand-side measures are necessary for health authorities to achieve desired savings from the availability of biosimilars.

Highlights

  • Biological medicines are among the most expensive medicines on the market, with average costs at approximately 22 times the cost of nonbiological drugs (Richardson, 2013)

  • The infliximab market size in terms of expenditure based on ex-factory prices has not changed significantly in all countries except Korea, where a substantial increase was observed (Figure 1A).the infliximab sales value in Korea increased by approximately 2.5 times compared with that the time when the biosimilar was first launched whereas other countries showed a minimal or steady trend overtime (20% in the UK and France, -10% in Japan after 12 quarters)

  • This study explored the market dynamics after the entry of biosimilar infliximab among four countries including the UK, France, Japan, and Korea, using 22 quarters of MIDAS-IQVIA observational data up to March 2018 focusing on the macro-level factors such as pricing and usage enhancing policies in each country

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Summary

Introduction

Biological medicines are among the most expensive medicines on the market, with average costs at approximately 22 times the cost of nonbiological drugs (Richardson, 2013). The impact of these products on overall health expenditures has rapidly increased (Elsevier Drug Information, 2017; GaBi, 2017; Gleeson et al, 2019). A number of standard biological medicines have faced patent expiration, sparking increased interest in biosimilars (Blackstone and Joseph, 2013; Mestre-Ferrandiz et al, 2016; GaBi, 2017; Moorkens et al, 2017; Santos et al, 2019). A number of biosimilars are expected to actively enter the market soon, helping to further address the budgetary concerns that have accompanied the increasing usage of highcost biological medicines (Moorkens et al, 2017). A better understanding of market dynamics upon the entry of biosimilars is needed to guide future activities

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