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Demonstration of Biosimilarity, Extrapolation of Indications and Other Challenges Related to Biosimilars in Europe

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Abstract

The regulatory framework for biosimilars was established across Europe in 2005 based on the concept of biosimilarity. This legislation secures the manufacturing, evaluation, and market authorization (MA) of high-quality safe and efficacious biopharmaceuticals that are highly similar to their reference medicinal product (biosimilars). Demonstration of biosimilarity is documented by full-scale comparability exercises between the biosimilar and the reference product at quality, preclinical, and clinical level. However, the complexity, diversity, and heterogeneity of biosimilars, both in structure and manufacturing, combined with the scientific knowledge accumulated in biotechnological analysis of recombinant therapeutic proteins requires continuous improvement of the regulatory framework based on the evolution and experience gained in this field. This current opinion article presents the concept of biosimilarity, discusses the extrapolation of indications that is acceptable based on a case-by-case basis by CHMP/EMA and uncovers other challenges lying ahead in the development of biosimilars. Biosimilars are still quite ‘young’ products that require worldwide attention.

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Acknowledgments

The authors would like to thank Dr. Christian K. Schneider of the Danish National Health and Medicines Authority, Copenhagen, Denmark, for reading the paper and providing constructive comments that improved this paper.

Disclaimer

The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or any of its committees or working parties.

Conflict of interest

The authors declare that they have no competing interests or other interests that may be perceived to influence the results and/or discussion reported in this current opinion article. Note: no funding has been received for the preparation of this manuscript.

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Authors and Affiliations

  1. Aristotle University of Thessaloniki, Thessaloniki, 54124, Greece

    Asterios S. Tsiftsoglou

  2. Department of Health Security and Public Health, School of Pharmacy, Paris-Descartes University, Paris, France

    Jean Hugues Trouvin

  3. Clinical Pharmacology, Hospital Clinique of Barcelona, Barcelona, Spain

    Gonzalo Calvo

  4. Spanish Medicines Agency, Madrid, Spain

    Sol Ruiz

Authors
  1. Asterios S. Tsiftsoglou
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  2. Jean Hugues Trouvin
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  3. Gonzalo Calvo
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  4. Sol Ruiz
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Corresponding author

Correspondence to Asterios S. Tsiftsoglou.

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Tsiftsoglou, A.S., Trouvin, J.H., Calvo, G. et al. Demonstration of Biosimilarity, Extrapolation of Indications and Other Challenges Related to Biosimilars in Europe. BioDrugs 28, 479–486 (2014). https://doi.org/10.1007/s40259-014-0109-y

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  • DOI: https://doi.org/10.1007/s40259-014-0109-y

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