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Related Experiment Videos

Commercial development considerations for biotechnology-derived therapeutics.

B J Marafino1, M K Pugsley

  • 1Department of Comparative Medicine, XOMA (US) LLC, Berkeley, CA 94710, USA.

Cardiovascular Toxicology
|April 2, 2003
PubMed
Summary

The US Food and Drug Administration (FDA) has approved 43 recombinant protein therapeutics, including monoclonal antibodies (MAbs), in the past 20 years. This burgeoning field shows an increasing pace of therapeutic innovation and approval.

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Area of Science:

  • Biotechnology
  • Pharmaceutical Science
  • Therapeutic Protein Development

Background:

  • The US Food and Drug Administration (FDA) approved the first recombinant protein therapeutic 20 years ago.
  • The development of protein therapeutics has seen significant growth since 1982.

Purpose of the Study:

  • To review the number and trend of recombinant protein therapeutic approvals by the FDA.
  • To highlight the increasing pace of innovation in protein-based drug development.

Main Methods:

  • Analysis of FDA approval data for recombinant protein therapeutics.
  • Tracking the number of approved monoclonal antibodies (MAbs) and other protein therapeutics over two decades.

Main Results:

  • A total of 43 recombinant protein therapeutics have been approved by the FDA in the past 20 years.

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  • An average of slightly more than two such therapeutics are approved annually.
  • The rate of approvals is accelerating.

    • Conclusions:

    • The field of recombinant protein therapeutics is rapidly expanding.
    • The increasing number of approvals signifies a growing trend in biopharmaceutical innovation.
    • Monoclonal antibodies (MAbs) represent a significant class of these therapeutics.