Academic journal article Applied Health Economics and Health Policy

Biosimilar Granulocyte Colony-Stimulating Factor Uptakes in the EU-5 Markets: A Descriptive Analysis

Academic journal article Applied Health Economics and Health Policy

Biosimilar Granulocyte Colony-Stimulating Factor Uptakes in the EU-5 Markets: A Descriptive Analysis

Article excerpt

Published online: 1 March 2014

© Springer International Publishing Switzerland 2014

Abstract

Background Biosimilars are copies of biological reference medicines. Unlike generics (copies of chemical molecules), biologics are complex, expensive and complicated to produce. The knowledge of the factors affecting the competition following patent expiry for biologics remains limited.

Objectives The aims of this study were to analyse the EU-5 Granulocyte-Colony Stimulating Factor (G-CSF) markets and to determine the factors affecting the G-CSF biosimilar uptakes, particularly that of biosimilar prices relative to originators.

Methods Data on medicine volumes, values, and ex-manufacturer prices for all G-CSF categories were provided by IMS Health. Volumes were calculated in defined daily doses (DDD) and prices in Euros per DDD. In the EU-5 countries, there is 5 years of experience with biosimilar G-CSFs (2007-2011).

Results TwoG-CSFmarket profiles exist: (1) countrieswith a high retail market distribution, which are the largest G-CSF markets with low global G-CSF biosimilar uptakes (5.4 % in France and 8.5 %inGermany in 2011); and (2) countrieswith a dominant hospital channel, which are the smallest markets with higher G-CSF biosimilar uptakes (12.4 % in Spain and 20.4 % in the UK). The more the decisions are decentralized, the more their uptakes are high. The price difference between G-CSF biosimilars and their reference plays amarginal role at a global level (price differences of ?13.3 % in the UK and -20.4 % in France).

Conclusion The competition with G-CSF biosimilars varies significantly between EU-5 countries, probably because of G-CSF distribution channel differences. Currently, this competition is not mainly based on prices, but on local political options to stimulate tendering between them and recently branded second- or third-generation products.

1 Background

The fabrication of generics, which are copies of off-patent chemical drugs, has increased sharply over the past 20 years and has generated significant savings for health systems. Since the first generics were marketed, the savings have been estimated at about euro30 billion in 2010 in the EU [1]. At this time, unprecedented patent expirations of expensive biological brands has created the opportunity for biological 'copies' (i.e. biosimilars) to enter the market and increase the competition among biologicals. Biosimilars could represent a significant potential savings for nations [2], although the factors that may influence the development of this market remain partly unknown. Biologicals are still a powerful driver of pharmaceutical innovation (e.g. in oncology, hematology and diabetes) [3] but represent significant costs to health systems, thereby threatening their accessibility and financial sustainability [4].

Unlike small chemical molecules, biologicals are proteins produced by living organisms, which are generally 100 to 1,000 times larger than chemical molecules and inherently more variable. They cannot be fully described physicochemically by current analytical methods, which are often insufficiently sensitive [5]. As a result, biosimilars cannot be structurally identical to their originators as is the case with generics. They are similar enough that no significant clinical difference exists between the biosimilar and the originator (i.e. reference product) [6]. Nonetheless, it must be remembered that the most minor changes in the manufacture of a biological molecule can have a major impact on biological activity and safety, as was observed with the emergence of pure red cell aplasia (PRCA), which was the cause of many patient deaths in the late 1990s because of a modification in the manufacturing process of an original epoetin alpha brand [7, 8]. Due to the complexity of biologicals, the generic pathway for regulatory approval cannot be used for biosimilars, and specific regulations for their development have been defined in the EU since 2004 [9]. …

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