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

Paubel, P.; Fusier, Isabelle; Cordonnier, Anne-Laure; Pen, Claude Le; Sinègre, M.

doi:10.1007/s40258-014-0087-8

Cited by 20 publications

(23 citation statements)

References 21 publications

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“…One study estimated the impact of biosimilar entry in terms of healthcare systems savings between 2007 and 2020 for eight EU countries (France, Germany, Italy, Poland, Romania, Spain, Sweden, and the UK), ranging from €11.8 billion to €33.4 billion [12]. Other qualitative studies assessed the levers and barriers to the uptake of biosimilars based on analysis of biosimilar uptake, price reduction, and various policies implemented across EU MS [2,8,[13][14][15][16][17] One quantitative study (Rovira et al [18]) assessed market dynamics of biosimilars in 24 EU MS, as well as Norway and Switzerland, between 2007 and 2010 using bivariate regression, and reported faster launch of biosimilars after marketing authorisation, associated to countries' gross national income and expenditure on health, pharmacists' generics substitution (inversely), and medicines' price level index. A recent survey providing an overview of pricing and reimbursement policy approaches across Europe for biological medicines, and specifically applied to biosimilars showed heterogeneity in policies and their implementation between the different countries [11].…”

Section: Background and Objectivementioning

confidence: 99%

“…Several factors have been reported as potential drivers of biosimilar uptake and might explain the differences observed between EU MS, i.e., physician and patient adoption of biosimilars, national healthcare systems specificities in terms of pricing, reimbursement, and procurement policies [4,19] Bocquet et al [16,20] reported that price difference between originator and biosimilar was not a main driver of EPO and G-CSF uptake; a low biosimilar uptake was partly explained by price cut of originators prior to biosimilar entry, as well as the development of new generation products competing with biosimilars. A recent study has shown a weak correlation between biosimilar uptake and price reduction [21].…”

Section: Background and Objectivementioning

confidence: 99%

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key Drivers for Market Penetration of Biosimilars in Europe

et al. 2016

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Background & Objectives: Potential drivers and barriers of biosimilar uptake were mainly analysed through qualitative approaches. The study objective was to conduct a quantitative analysis and identify drivers of biosimilar uptake of all available biosimilars in the European Union (EU). Methods: A three-step process was established to identify key drivers for the uptake of biosimilars in the top 10 EU member states (MS) pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK): (1) literature review to identify incentive policies in place to enhance biosimilars adoption; (2) assessment of biosimilar market dynamics based on database analysis; (3) regression model analysis on price using the following explicative variables: incentive policies; price difference between the biosimilar and the originator product; distribution channel; generic uptake and generic price cut; pharmaceutical expenditure per capita; and market competition. Results: At the study cut-off date, 20 biosimilars were available on the market. Incentive policies applied to biosimilars were found to be heterogeneous across countries, and uptakes of biosimilars were also very heterogeneous between different therapeutic classes and countries. Results from the model demonstrated that incentive policies and the date of first biosimilar market entry were correlated to biosimilar uptake. Pharmaceutical expenditure per capita and the highest generic uptake were inversely correlated with biosimilar uptake. Average generic price discount over originator and the number of biosimilars showed a trend toward statistical significance for correlation with biosimilar uptake, but did not reach the significance threshold. Biosimilar price discount over original biologic price, the number of analogues, and the distribution channel were not correlated with the biosimilar uptake. Conclusions: Understanding drivers of biosimilar uptake becomes a critical issue to inform policy decision-makers. This study showed that incentive policies to enhance uptake remain an important driver of biosimilar penetration, while biosimilar price discounts have no impact. Future research is warranted when the biosimilar market gains maturity.

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Section: Background and Objectivementioning

confidence: 99%

Section: Background and Objectivementioning

confidence: 99%

key Drivers for Market Penetration of Biosimilars in Europe

et al. 2016

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“…Internal reference pricing [19][20][21][22][23][24] IRP is in place for biosimilars in five (France, Germany, Hungary, Poland, and Spain) out of the 10 selected countries, at the fourth Anatomical Therapeutic Chemical (ATC) classification level (therapeutic/pharmacological/ chemical subgroup) and/or at the fifth level (chemical substance) [25]. In Hungary, there is also a policy called 'preferred reference pricing system', applicable when more than two versions of a biologic medicine are available; this policy sets preferred price ranges based on the reference price for reimbursement, i.e.…”

Section: Supply-side Policies For Biosimilarsmentioning

confidence: 99%

Supply-Side and Demand-Side Policies for Biosimilars: An Overview in 10 European Member States

Rémuzat

Kapuśniak²,

Caban³

et al. 2016

Value in Health

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Objective: This study aimed to provide an overview of biosimilar policies in 10 EU MSs. Methods: Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK) were selected. A comprehensive literature review was performed to identify supply-side and demand-side policies in place in the selected countries. Results: Supply-side policies for biosimilars commonly include price linkage, price re-evaluation, and tendering; the use of internal or external reference pricing varies between countries; health technology assessment is conducted in six countries. Regarding demand-side policies, pharmaceutical prescription budgets or quotas and monitoring of prescriptions (with potential financial incentives or penalties) are in place in eight and in seven countries respectively. Switching is generally allowed, but is solely the physician's responsibility. Automatic substitution is not recommended, or even forbidden, in most EU MSs. Prescription conditions or guidelines that apply to biosimilars are established in nearly all surveyed EU MSs. Conclusions: Important heterogeneity in policies on biosimilars was seen between (and even within) selected countries, which may partly explain variations in biosimilar uptake. Supply-side policies targeting price have been reported to limit biosimilar penetration in the long term, despite short-term savings, while demand-side policies are considered to positively impact uptake. ARTICLE HISTORY

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“…In order to describe the dynamics at work on the biosimilar market and to determine the biosimilar capacity to compete with other biologics-and after having previously analyzed the G-CSF market 8 -the EPO market was a natural analysis to make in retrospect 9,10 . The EPO class is that which generates more expenses around the world (7.6 billion dollars in 2012), where the highest number of biosimilars can be found, for which the number of laboratories is the most important and for which we have the highest number of biosimilar-using experiences.…”

mentioning

confidence: 99%

“…In Germany, the heterogeneously implemented incentives promoting the use of biosimilars seem to significantly increase the EPO-BIOSIM uptake. Their impact nonetheless has to be put into perspective, as biosimilar G-CSF uptakes in Germany remain weak in relation to other European countries, which have not implemented equivalent incentives 8 . Moreover, the non-coercive aspect of implemented quotas cannot guarantee their real efficiency, and other studies show that biosimilar uptake rates can easily vary from one German region to another 11 .…”

mentioning

confidence: 99%