Oncologie

, Volume 13, Issue 5, pp 218–221 | Cite as

Market access of biosimilars: not only a cost issue

Synthèse / Review Article

Abstract

This article discusses specific issues related to the market access of biosimilars. Biopharmaceuticals are complex molecules produced by living cells. Copies of these medicines, called biosimilars, are not identical to their reference medicine and, therefore, specific regulatory requirements apply. When considering the use of biosimilars, the question of the degree of comparability between a biosimilar and the reference biopharmaceutical needs to be considered for registration, pricing and reimbursement purposes in addition to the cost issue. To date, many key concepts (like clinically meaningful differences) remain undefined and the question of the degree of comparability is not yet resolved.

Keywords

Biopharmaceutical Biosimilar Registration Pricing Reimbursement 

L’accès au marché par les biosimilaires: pas seulement un problème de coût

Résumé

Cet article aborde les problèmes spécifiques liés à l’accès au marché par les biosimilaires. Les produits biopharmaceutiques sont des molécules complexes produites par des cellules vivantes. Les copies de ces médicaments, appelées biosimilaires, diffèrent de leur médicament de référence, et c’est la raison pour laquelle on a imposé des exigences réglementaires spécifiques. Lorsqu’on étudie l’utilisation des biosimilaires, il est nécessaire de réfléchir, aux fins d’enregistrement, de tarification et de remboursement, en plus du problème de coût, au degré de comparabilité entre un biosimilaire et le produit biopharmaceutique de référence. À ce jour, de nombreux concepts clés (tels que les différences cliniquement significatives) demeurent flous et la question du degré de comparabilité reste en suspens.

Mots clés

Produit biopharmaceutique Biosimilaire Enregistrement Tarification Remboursement 

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Copyright information

© Springer Verlag France 2011

Authors and Affiliations

  1. 1.Research Centre for Pharmaceutical Care and Pharmaco-economics, Faculty of Pharmaceutical SciencesKatholieke Universiteit LeuvenLeuvenBelgium
  2. 2.Laboratory for Molecular and Cellular Technology, Burn Wound CentreQueen Astrid Military HospitalBrusselsBelgium

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