BMJ  2005;331:895-897 (15 October), doi:10.1136/bmj.331.7521.895

Education and debate

Disappointing biotech

Roberta Joppi, visiting scientist1, Vittorio Bertele', head, regulatory policy laboratory1, Silvio Garattini, director1

1 Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milan, Italy

Correspondence to: S Garattini garattini@marionegri.it

Biotechnology offered the hope of cheaper and better drugs. Analysis of biotech products licensed in Europe shows the reality is somewhat different

The first 150 words of the full text of this article appear below.

Introduction

The advent of DNA recombinant techniques and other biotechnologies has raised expectations for more selective drugs. The techniques promise "magic bullets" that are better tolerated because they are more similar to endogenous products and cheaper to make thanks to potential large scale production. Thus biotech products offer a good model for assessing the level of therapeutic innovation of drugs. We assessed the biotech medicines approved by the European Medicine Evaluation Agency from its inception in 1995 to 2003, when the European pharmaceutical law was revised.1 The agency approved 87 biotech products, corresponding to 65 active ingredients, during this period. Four were approved for diagnostic purposes. How innovative were the 61 licensed with more therapeutic indications?

Innovation of biotech substances

The box shows the 61 active substances classified according to their type of benefit compared with existing treatment or placebo, as appropriate (see bmj.com for details of the indications). We obtained the information from the . . . [Full text of this article]

Evidence supporting innovation

Poorly assessed poor innovation


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