ArticlePharmacoEconomics2016
Competition Between Biosimilars and Patented Biologics: Learning from European and Japanese Experience.
Article in PharmacoEconomics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed.
- Individual Prescribing Incentives for Biosimilars in Selected European Countries and the USA: a Scoping Literature Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- List prices and clinical value of anticancer drugs in China, Japan, and South Korea: a retrospective comparative study.The Lancet regional health. Western Pacific · 2024Article
- Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany.Pharmaceuticals (Basel, Switzerland) · 2020Article
- Physician-Level Cost Control Measures and Regional Variation of Biosimilar Utilization in Germany.International journal of environmental research and public health · 2020Article
- Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Review
- Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.The oncologist · 2019Article
- Biosimilars in the USA: Will New Efforts to Spur Approvals and Access Spur Uptake and Cost Savings?Pharmaceutical medicine · 2019Article
- Cell line access to revolutionize the biosimilars market.F1000Research · 2018Article
- Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017Review
- The Rituximab Biosimilar CT-P10 in Rheumatology and Cancer: A Budget Impact Analysis in 28 European Countries.Advances in therapy · 2017Article
- Drug tendering: drug supply and shortage implications for the uptake of biosimilars.ClinicoEconomics and outcomes research : CEOR · 2017Review
- Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe expiry of patents for costly biologics is creating new momentum on the pharmaceutical market for biosimilars (copies of off-patent biologics) and paving the way for their development. However, little is known about the competitiveness of biosimilars versus their originators and other biologics belonging to the same therapeutic class.
objectiveThe main goal of this study was to analyse the type of competition generated by the first biosimilars commercialised on key global biologic markets and to grasp their economic model. The secondary goal was to distinguish the main factors likely to influence the uptake of biosimilars on national markets.
methodsTo be included in this study, countries had to meet three conditions: the regulatory framework for the development of biosimilars closely resembled that in Europe, biosimilars were marketed in 2014, and the value of the biologics market was >US$3 billion. We analysed granulocyte colony-stimulating factors (GCSFs) and erythropoietins (EPOs) over the period 2007-2014 because these are the two main therapeutic classes that have been 'biosimilarised' and thus have many years of experience available. We assessed market sizes, retail/hospital distribution mixes, incentives for using biosimilars and price discounts for originators versus biosimilars. We conducted a linear regression analysis to assess the relationship between uptakes of biosimilars and the market shares of other biologics.
resultsThe EU-5 (France, Germany, Italy, Spain and the UK) and Japanese GCSF and EPO markets are highly-country-specific. Uptake of biosimilars seems to depend on retail/hospital distribution mixes and on medical practice. Depending on the therapeutic class and the market sector (retail or hospital), biosimilars may compete with first-generation or second-generation products or both. Some incentives implemented to encourage the use of biosimilars had mixed results. Overall, discounts for biosimilars versus originators are not factors that determine global uptake of biosimilars.
conclusionUnlike generics, there appears to be no unique economic model for biosimilars. Moreover, a new phenomenon occurs with biosimilars: sometimes, they are able to take market shares from subsequent generations of biologics.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.