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Biosimilar Drugs

Concerns and Opportunities

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Abstract

Patents for biologic agents first marketed in the 1980s are now beginning to expire, opening the door for ‘nonproprietary’ versions of these agents to enter the market. However, there are fundamental differences between biologics and traditional pharmaceuticals that preclude the extrapolation of existing regulatory processes for traditional generic agents to these new biologic products. These include differences in dimensions (molecular weight), synthesis, purification, stability, and immunogenicity. There is also controversy over the terminology of these biologic agents, with a number of terms put forward. European regulatory authorities have adopted the term ‘biosimilars,’ while the US FDA prefers the term ‘follow-on biologics.’ It is important that these terms are not used as synonyms for ‘generics,’ and already there are moves to prevent classification of these products as ‘generics.’ In this review, we focus on the differences that exist between generics and biosimilars, and assess the current scenario of problems and opportunities. Furthermore, we also attempt to highlight the problems with establishing regulatory guidelines and those associated with the introduction of these drugs into clinical practice.

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Acknowledgments

The article was written on behalf of the Italian Pharmacological Society Council. The manuscript did not receive any industry support. Pier Luigi Canonico is a member of an advisory board for Amgen, and several other pharmaceutical companies active in the biotechnology field. He has also received research grants from Amgen, Eli Lilly, GSK, Pfizer, Astra Zeneca, Novartis, and Lundbeck, all for projects unrelated to biosimilars. The other authors have no conflicts of interest to disclose that are directly relevant to the content of this article.

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Authors and Affiliations

  1. DiSCAFF, Department of Chemical, Food, Pharmaceutical and Pharmacological Sciences, University of Piemonte Orientale ‘A., Avogadro’, Novara, Italy

    Armando A. Genazzani &  Pier Luigi Canonico

  2. Department of Experimental Biology Bernardo Loddo, Section of Neuroscience, University of Cagliari, Cittadella Universitaria, Cagliari, Italy

    Giovanni Biggio

  3. Department of Clinical and Experimental Medicine and Pharmacology, Pharmacology Unit, University of Messina, Messina, Italy

    Achille Patrizio Caputi

  4. Division of Pharmacology and Chemotherapy, Department of Internal Medicine, University of Pisa, Pisa, Italy

    Mario Del Tacca

  5. Department of Experimental and Clinical Pharmacology, School of Medicine, University of Catania, Catania, Italy

    Filippo Drago

  6. Departments of Anatomy, Pharmacology, and Forensic Medicine, University of Turin, Turin, Italy

    Roberto Fantozzi

Authors
  1. Armando A. Genazzani
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  2. Giovanni Biggio
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  3. Achille Patrizio Caputi
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  4. Mario Del Tacca
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  5. Filippo Drago
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  6. Roberto Fantozzi
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  7. Pier Luigi Canonico
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Corresponding author

Correspondence to Pier Luigi Canonico.

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Genazzani, A.A., Biggio, G., Caputi, A.P. et al. Biosimilar Drugs. BioDrugs 21, 351–356 (2007). https://doi.org/10.2165/00063030-200721060-00003

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