Education And Debate

Disappointing biotech

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7521.895 (Published 13 October 2005) Cite this as: BMJ 2005;331:895
  1. Roberta Joppi, visiting scientist1,
  2. Vittorio Bertele, head, regulatory policy laboratory1,
  3. Silvio Garattini (garattini@marionegri.it), director1
  1. 1 Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milan, Italy
  1. Correspondence to: S Garattini
  • Accepted 29 June 2005

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 European public statements, available on the EMEA website (www.emea.eu.int/index/indexh1.htm). Only 15 products represented therapeutic innovation, that is, drugs for diseases without effective treatment, more effective than existing treatment, or active in patients resistant to current treatment. Twenty two offered limited non-therapeutic advantages over existing products (10 in terms of safety and 12 in terms of convenience), and 24 were copycat or me too products.

The …

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