Bocquet F (1), (2), (3), Paubel P (2), Fusier I (3), Cordonnier AL (3), Le Pen C (1), Sinègre N (3)
(1) Dauphine University, Paris, France, (2) Paris Descartes University, France, (3) General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP), France
Objectives:
To determine the ability of biosimilars (copies of branded biologics) to compete with brand name biologics within the same therapeutic class by analyzing EU-5 G-CSF (Granulocyte-Colony Stimulating Factors) markets and the factors affecting the G-CSF biosimilar uptakes, particularly that of biosimilar prices relative to reference G-CSFs.
Methods:
Data on medicine volumes, values and ex-manufacturer prices for all G-CSF categories were provided by IMS Health. Volumes were calculated in DDD (Defined Daily Doses) and prices in euros per DDD. In the EU-5 countries biosimilar G-CSFs benefit from a 5-year experience. Data were available from 2007 until 2011.
Results:
There are two G-CSF market profiles: i) countries with 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); ii) countries with 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 G-CSF biosimilar uptakes depend critically on their market access at a local/regional level. The more the decisions are decentralized (hospitals, local purchasing structures) the more their uptakes are high (28.3% of the hospital market in France in 2011 and 20.4% in the UK). The price difference between G-CSF biosimilars and their reference plays a marginal role at a global level (+13.3% in the UK and -20.4% in France).
Conclusions:
The competition with G-CSF biosimilars varies significantly between EU-5 countries due to distribution channel differences. Currently, this competition is not mainly based on prices, but on local political options to stimulate tendering between them and other most recently branded products. In countries with dominant retail markets, a prerequisite for the success of biosimilar G-CSFs is that governments approve their substitution in the same way generics are authorized by introducing them case-by-case.