Follow-on protein products: scientific issues, developments and challenges

Trends Biotechnol. 2009 Dec;27(12):698-705. doi: 10.1016/j.tibtech.2009.09.004. Epub 2009 Oct 19.


Scientific and regulatory issues around approval of follow-on protein products, referred to as biosimilars in Europe, have been a topic of great interest and debate recently. The central issue is our limited understanding of how the different quality attributes of a product have an impact on its safety and efficacy. Crucial gaps in our knowledge include a lack of standardization in the way in which data are collected, analyzed and reported, and limitations in the ability of non-clinical tools for predicting clinical safety and efficacy. Complexity of protein products with respect to the numerous quality attributes and complexity of the biotechnology processes and the raw materials add to the challenges. In this paper, recommendations are presented to help at least partially alleviate these challenges.

Publication types

  • Review

MeSH terms

  • Biological Products / adverse effects
  • Biological Products / chemistry*
  • Biological Products / therapeutic use*
  • Biotechnology / methods*
  • Biotechnology / standards*
  • Drug Approval / methods*
  • Europe
  • Humans
  • Proteins / adverse effects
  • Proteins / therapeutic use*


  • Biological Products
  • Proteins