ArticleBritish journal of clinical pharmacology2006
An update on the first decade of the European centralized procedure: how many innovative drugs?
Article in British journal of clinical pharmacology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Who cites it
17 citing papers in PubMed.
- Methods for Assessing Therapeutic Innovation of Drugs: Changes at the Italian Medicine Agency.Therapeutic innovation & regulatory science · 2026Article
- New drugs and their performance 10 years after approval: a systematic analysis.Naunyn-Schmiedeberg's archives of pharmacology · 2025Article
- Current landscape of innovative drug development and regulatory support in China.Signal transduction and targeted therapy · 2025Review
- Level of therapeutic innovation from the registration studies of the new drugs for the prophylaxis of migraine.Journal of clinical pharmacy and therapeutics · 2022Article
- Regulatory policy and pharmaceutical innovation in the United Kingdom after Brexit: Initial insights.Frontiers in medicine · 2022Article
- Few new drugs deserve expedited regulatory treatment.Journal of managed care & specialty pharmacy · 2021Article
- EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations.Epidemiology and psychiatric sciences · 2021Article
- Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation.Frontiers in pharmacology · 2017Review
- Observational
- Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation.The European journal of health economics : HEPAC : health economics in prevention and care · 2014Article
- Pharmaceutical innovation: impact on expenditure and outcomes and subsequent challenges for pharmaceutical policy, with a special reference to Greece.Hippokratia · 2014Review
- Article
- Assessment of the therapeutic value of new medicines marketed in Australia.Journal of pharmaceutical policy and practice · 2013Article
- A 3-dimensional view of access to licensed and subsidized medicines under single-payer systems in the US, the UK, Australia and New Zealand.PharmacoEconomics · 2012Article
- EMA's reflection on placebo does not reflect patients' interests.European journal of clinical pharmacology · 2012Article
- Defining innovations of therapeutic interventions: a position paper by the Italian Society of Hospital Pharmacists.International journal of clinical pharmacy · 2012Article
- The Italian Horizon Scanning Project.European journal of clinical pharmacology · 2009Article
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsIn a previous paper, we proposed an algorithm to assess the degree of therapeutic innovation of the agents approved by the European centralized procedure, which must be followed by biotechnological products and is optional for drugs claimed as innovative. A low overall degree of therapeutic innovation (about 30%) was found. This figure may be an underestimate of the actual level of innovation, because common biotechnological products, such as recombinant human insulins, must follow this procedure. To test the hypothesis that therapeutic innovation prevails among nonbiotechnological products, we evaluated separately the degree of therapeutic innovation of biotechnological vs. nonbiotechnological agents in the first decade of European Medicines Agency activity, also studying a possible time trend.
methodsWe assessed, for each drug: (i) the seriousness of the target disease, (ii) the availability of previous treatments, and (iii) the extent of therapeutic effect according to the previously proposed algorithm.
resultsOur analysis considered 251 medicinal products corresponding to 198 active substances, classified according to four main areas as therapeutic agents (88.9%), diagnostics (5.5%), vaccines (5.1%) and life-style drugs (0.5%). Among all therapeutic agents, 49 out of 176 agents (28%) were classified as having an important degree of therapeutic innovation. Fifteen out of 60 biotechnological therapeutic agents were considered important therapeutic innovations (25%), whereas this figure was 29% for nonbiotechnological agents.
conclusionsAmong active substances claimed as innovative by the manufacturers, only a minority deserve this definition according to our algorithm.
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