OBJECTIVES : This study aims to examine how several factors, especially regional-level differences in policy measures and practices, influence market dynamics of infliximab and etanercept biosimilars and originators in Germany.

METHODS : First, a literature review was conducted on (biosimilar) policies in Germany. Second, regional dispensing data were analysed using the database of the German Institute for Drug Use Evaluation (DAPI) with respect to TNFα inhibitor originators and biosimilars (Q1 2010 to Q4 2018). Third, ten semi-structured interviews were conducted to investigate prescribers’ and insurers’ views at the national and regional level.

RESULTS : The analysis of biosimilar market shares of infliximab and etanercept across Germany’s 17 regions of the Regional Association of Statutory Health Insurance Accredited Physicians revealed wide variations. Similar uptake patterns were described for infliximab and etanercept biosimilars, allowing to identify common low- and high-uptake regions. Sachsen, Sachsen-Anhalt, Brandenburg, Berlin and Baden-Württemberg showed low uptake for both infliximab and etanercept biosimilars. Niedersachsen, Westfalen-Lippe, Bayern and Nordrhein showed high uptake for both infliximab and etanercept biosimilars. Quantitative analysis indicated that 36% (p ≤ 0.05) and 39% (p ≤ 0.05) of the variability in biosimilar market shares for infliximab and etanercept, respectively, could be explained by the East/West location of the regions. In addition, qualitative interview analysis illustrated that the use of biosimilars may depend on: (1) the regional-level implementation of biosimilar quotas and the presence of monitoring/sanctioning mechanisms which ensure adherence to these quotas, (2) the different insurer-manufacturer discount contracts established at the regional level, and (3) the organization of initiatives for gainsharing at the insurer-prescriber level.

CONCLUSIONS : Uptake of biosimilars in Germany is region specific and is driven by a complex interplay of factors. This study has emphasized the role of prescription and drug budget control activities in driving variable biosimilar uptake for infliximab and etanercept across Germany.