BioDrugs

, Volume 21, Issue 6, pp 351–356

Biosimilar Drugs

Concerns and Opportunities
  • Armando A. Genazzani
  • Giovanni Biggio
  • Achille Patrizio Caputi
  • Mario Del Tacca
  • Filippo Drago
  • Roberto Fantozzi
  • Pier Luigi Canonico
Current Opinion

DOI: 10.2165/00063030-200721060-00003

Cite this article as:
Genazzani, A.A., Biggio, G., Caputi, A.P. et al. BioDrugs (2007) 21: 351. doi:10.2165/00063030-200721060-00003

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.

Copyright information

© Adis Data Information BV 2007

Authors and Affiliations

  • Armando A. Genazzani
    • 1
  • Giovanni Biggio
    • 2
  • Achille Patrizio Caputi
    • 3
  • Mario Del Tacca
    • 4
  • Filippo Drago
    • 5
  • Roberto Fantozzi
    • 6
  • Pier Luigi Canonico
    • 1
  1. 1.DiSCAFF, Department of Chemical, Food, Pharmaceutical and Pharmacological SciencesUniversity of Piemonte Orientale ‘A.Avogadro’Italy
  2. 2.Department of Experimental Biology Bernardo Loddo, Section of NeuroscienceUniversity of Cagliari, Cittadella UniversitariaCagliariItaly
  3. 3.Department of Clinical and Experimental Medicine and Pharmacology, Pharmacology UnitUniversity of MessinaMessinaItaly
  4. 4.Division of Pharmacology and Chemotherapy, Department of Internal MedicineUniversity of PisaPisaItaly
  5. 5.Department of Experimental and Clinical Pharmacology, School of MedicineUniversity of CataniaCataniaItaly
  6. 6.Departments of Anatomy, Pharmacology, and Forensic MedicineUniversity of TurinTurinItaly
  7. 7.Dipartimento di Scienze Chimiche, Alimentari, Farmaceutiche Farmacologiche and Drug and Food Biotechnology CenterUniversity of Piemonte Orientale ‘A. Avogadro’NovaraItaly

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