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. 2020 Oct 21;13(10):324.
doi: 10.3390/ph13100324.

Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany

Evelien Moorkens  1 , Teresa Barcina Lacosta  1 , Arnold G Vulto  1   2 , Martin Schulz  3   4   5 , Gabriele Gradl  5 , Salka Enners  5 , Gisbert Selke  6 , Isabelle Huys  1 , Steven Simoens  1
Affiliations

Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany

Evelien Moorkens et al. Pharmaceuticals (Basel). .

Abstract

Drug budget and prescription control measures are implemented regionally in Germany, meaning that the uptake of pharmaceuticals, including biosimilars, can vary by region. We examine regional market dynamics of tumor necrosis factor alpha (TNFα) inhibitor originators and biosimilars in Germany and studied the influence of biosimilar policies on these dynamics. This study is based on: (1) a literature review in which German biosimilar policies are identified, (2) the analysis of dispensing data (2010-2018) for the class of TNFα inhibitors, and (3) ten semi-structured interviews investigating prescribers' and insurers' views on factors potentially influencing biosimilar uptake. The analysis of biosimilar market shares of infliximab and etanercept revealed wide variations across the 17 German Regional Associations of Statutory Health Insurance Accredited Physicians (PA regions). Quantitative analyses indicated that biosimilar market shares for infliximab and etanercept were significantly lower in former East Germany when compared to former West Germany regions. Through qualitative interview analyses, this study showed that the use of infliximab and etanercept biosimilars across Germany is primarily influenced by (1) the regional-level implementation of biosimilar quotas and the presence of monitoring/sanctioning mechanisms to ensure adherence to these quotas, (2) the different insurer-manufacturer discount contracts, and (3) gainsharing arrangements established at the insurer-prescriber level.

Keywords: Germany; TNFα inhibitors; biologics; biosimilars; etanercept; incentives; infliximab; market dynamics; policies; uptake.

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Conflict of interest statement

S.S., I.H. and A.G.V. have founded the KU Leuven Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL). S.S. was involved in a stakeholder roundtable on biologics and biosimilars sponsored by Amgen, Pfizer and MSD; he has participated in advisory board meetings for Pfizer and Amgen; he has contributed to studies on biologics and biosimilars for Hospira (together with A.G.V. and I.H.), Celltrion, Mundipharma and Pfizer, and he has had speaking engagements for Amgen and Sandoz. A.G.V. is involved in consulting, advisory work and speaking engagements for a number of companies, a.o. AbbVie, Accord, Amgen, Biogen, EGA, Pfizer/Hospira, Mundipharma, Roche, Sandoz. E.M., T.B.L., G.G., S.E., M.S. and G.S. declare no conflict of interest.

Figures

Figure 1
Figure 1
Sales volume evolution (2010–2018) expressed as a percentage of 2010 volume and measured as defined daily doses (DDDs) for originator and biosimilar products containing infliximab, etanercept and adalimumab (primary axis). Year-over-year (YoY) growth (%) is represented on the secondary axis. Compound annual growth rate (CAGR) is calculated before and after biosimilar launch. The graphical representation of the data is based on a figure published by IQVIA [26].
Figure 2
Figure 2
Composition of the market for TNFα inhibitors in terms of individual products from 2010 to 2018. The sales volume (DDDs) for infliximab (originator + biosimilars), etanercept (originator + biosimilars), adalimumab (originator + biosimilars), certolizumab pegol and golimumab is expressed as a share of the total volume of TNFα inhibitors.
Figure 3
Figure 3
Composition of the market for TNF α inhibitors in terms of biosimilar products (2015–2018). Biosimilar market shares (%) for infliximab and etanercept are calculated in relation to the total volume of TNFα inhibitors.
Figure 4
Figure 4
Biosimilar penetration for infliximab and etanercept in Germany over time. Biosimilar market shares (%) are calculated as volume of biosimilars over volume of biosimilars plus the originator product (DDDs).
Figure 5
Figure 5
(a) Market shares (%) of biosimilar infliximab in Q4 2018. (b) Market shares (%) of biosimilar etanercept in Q4 2018. (c) Low- and high-uptake PA regions which are common for infliximab and etanercept biosimilars in Q4 2018. The dotted pattern refers to regions with high biosimilar uptake for both infliximab and etanercept. The crossed pattern refers to regions with low biosimilar uptake for both infliximab and etanercept. The map templates were extracted from mapchart.net.
See this image and copyright information in PMC

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