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Resume Le medicament biosimilaire (BS) correspond a un medicament biologique declare comme similaire a un medicament biologique de reference et dont le plan de developpement inclut des etudes de comparaison par rapport a la reference, afin de confirmer la similarite du produit au niveau qualite, securite preclinique, et profil d’efficacite et de securite cliniques dont l’immunogenicite. Les biosimilaires (BS) sont differents des generiques, tant par leur complexite moleculaire que par leur reglementation. Ils representent des enjeux economiques considerables avec l’expiration dans les 5 prochaines annees des brevets de nombreux biomedicaments couvrant des aires therapeutiques majeures comme la cancerologie, la rhumatologie ou la gastroenterologie, qui representent des depenses importantes pour l’Assurance maladie. La table ronde (TR) a emis des recommandations pour que l’arrivee des BS soit un succes, en s’appuyant sur le medecin prescripteur comme acteur de l’information et de la confiance, en mettant en place un suivi des patients traites par biomedicaments, et en accelerant l’acces au marche de leurs biosimilaires.

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.

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.