Biosimilars: from technical to pharmacoeconomic considerations. 30th Rencontres Nationales de Pharmacologie et Recherche clinique pour l'Innovation et l'Evaluation des Technologies de Santé. Tables rondes
Therapie. 2015 Jan-Feb;70(1):37-55.
doi: 10.2515/therapie/2015003.
Epub 2015 Feb 16.
[Article in
English,
French]
Authors
Danièle Girault
1
, Jean-Hugues Trouvin
2
, Corinne Blachier-Poisson
3
, François Gary
4
, Didier Laloye
5
; participants of round table N°3 of Giens XXX:; Jean-François Bergmann
6
, Nicole Casadevall
7
, Cécile Delval
8
, Rima De Sahb Berkovitch
9
, Jean-Yves Fagon
10
, Marta Gersberg
11
, Catherine Lassale
12
, Philippe Lechat
13
, Claire Le Jeunne
14
, Jean-Louis Montastruc
15
, Jean-Louis Prugnaud
7
, Christelle Ratignier-Carbonneil
16
, Cécile Rey-Coquais
17
; 30th Rencontres Nationales de Pharmacologie et Recherche clinique pour l'Innovation et l'Evaluation des Technologies de Santé
Affiliations
- 1 Laboratoire Novartis Pharma, Rueil Malmaison, France.
- 2 Université Paris Descartes, Faculté de Pharmacie, France.
- 3 Laboratoire Amgen, Neuilly-sur-Seine, France.
- 4 Laboratoire Sandoz, Levallois Perret, France.
- 5 Hospira France, Meudon la Forêt, France.
- 6 Hôpital Lariboisière, AP-HP, Paris, France.
- 7 Hôpital Saint Antoine, AP-HP, Paris, France.
- 8 ANSM, Saint Denis, France.
- 9 Laboratoire MSD, Courbevoie, France.
- 10 CEPS, HEGP, Paris, France.
- 11 Marta Gersberg Conseil, Chatou, France.
- 12 LEEM, Paris, France.
- 13 Hôpital Saint Louis, AP-HP, Paris, France.
- 14 Hôpital Cochin, AP-HP, Paris, France.
- 15 CHU, Faculté de Médecine, Toulouse, France.
- 16 CNAMTS, Paris, France.
- 17 Laboratoire Pfizer, Paris, France.
Abstract
A biosimilar is a biological medicinal product claimed to be similar to a reference biological medicinal product. Its development plan includes studies comparing it with the reference product in order to confirm its similarity in terms of quality, preclinical safety, clinical efficacy, and clinical safety, including immunogenicity. Biosimilars differ from generics both in their molecular complexity and in the specific requirements that apply to them. Since patents on many biological medicinal products will expire within the next 5 years in major therapeutic areas such as oncology, rheumatology and gastroenterology and as those products are so costly to the French national health insurance system, the availability of biosimilars would have a considerable economic impact. The round table has issued a number of recommendations intended to ensure that the upcoming arrival of biosimilars on the market is a success, in which prescribing physicians would have a central role in informing and reassuring patients, an efficient monitoring of the patients treated with biologicals would be set up and time to market for biosimilars would be speeded up.
© 2015 Société Française de Pharmacologie et de Thérapeutique.
MeSH terms
-
Biosimilar Pharmaceuticals* / economics
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Biosimilar Pharmaceuticals* / supply & distribution
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Biosimilar Pharmaceuticals* / therapeutic use
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Drug Costs
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France
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Humans
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Marketing of Health Services / legislation & jurisprudence
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Medical Records / standards
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National Health Programs / economics
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Pharmacies / organization & administration
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Pharmacies / standards
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Product Surveillance, Postmarketing / standards
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Reimbursement Mechanisms
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Risk Management / standards
Substances
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Biosimilar Pharmaceuticals