title: Biosimilars: from Technical to Pharmacoeconomic Considerations.
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.
authors.affiliation: Laboratoire Novartis Pharma, Rueil Malmaison, France. Electronic address: daniele.girault@novartis.com.
authors.forename: Danièle
authors.initials: D
authors.lastname: Girault
authors.affiliation: Université Paris Descartes, Faculté de Pharmacie, France.
authors.forename: Jean-Hugues
authors.initials: JH
authors.lastname: Trouvin
authors.affiliation: Laboratoire Amgen, Neuilly-sur-Seine, France.
authors.forename: Corinne
authors.initials: C
authors.lastname: Blachier-Poisson
authors.affiliation: Laboratoire Sandoz, Levallois Perret, France.
authors.forename: François
authors.initials: F
authors.lastname: Gary
authors.affiliation: Hospira France, Meudon la Forêt, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Laloye
authors.affiliation: Hôpital Lariboisière, AP-HP, Paris, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Bergmann
authors.affiliation: Hôpital Saint Antoine, AP-HP, Paris, France.
authors.forename: Nicole
authors.initials: N
authors.lastname: Casadevall
authors.affiliation: ANSM, Saint Denis, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Delval
authors.affiliation: Laboratoire MSD, Courbevoie, France.
authors.forename: Rima
authors.initials: R
authors.lastname: De Sahb Berkovitch
authors.affiliation: CEPS, HEGP, Paris, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Fagon
authors.affiliation: Marta Gersberg Conseil, Chatou, France.
authors.forename: Marta
authors.initials: M
authors.lastname: Gersberg
authors.affiliation: LEEM, Paris, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Lassale
authors.affiliation: Hôpital Saint Louis, AP-HP, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Lechat
authors.affiliation: Hôpital Cochin, AP-HP, Paris, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Le Jeunne
authors.affiliation: CHU, Faculté de Médecine, Toulouse, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Montastruc
authors.affiliation: Hôpital Saint Antoine, AP-HP, Paris, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Prugnaud
authors.affiliation: CNAMTS, Paris, France.
authors.forename: Christelle
authors.initials: C
authors.lastname: Ratignier-Carbonneil
authors.affiliation: Laboratoire Pfizer, Paris, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Rey-Coquais
keywords: biosimilar pharmaceuticals; health care costs; risk management; substitution; traceability