François Bocquet (1) (2) (3), Pascal Paubel (3), Isabelle Fusier, Anne-Laure Cordonnier, Claude Le Pen (2), Martine Sinègre. Appl Health Econ Health Policy, 2014; 12 (3) : 315-326.
(1) Therapeutic Evaluation Unit, General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France
(2) Dauphine University, Paris, France
(3) Faculty of Pharmacy, Paris Descartes University, Health Law Institute, Inserm, UMR S 1145,Sorbonne Paris
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 exmanufacturer 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 %in Germany 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 a marginal 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.
Article publié dans le numéro de numéro 3 (volume 12) de 2014 de la revue Applied Health Economics and Health Policy.