Activation de la cellule endothéliale en conditions xénogéniques et modulation par les immunoglobulines humaines intraveineuses

PARIS7-Bibliothèque centrale (751132105) / SudocSudocFranceF

Activation de la cellule endothéliale en conditions xénogéniques et modulation par les immunoglobulines humaines intraveineuses

PARIS7-Bibliothèque centrale (751132105) / SudocSudocFranceF

The French reporting system for drug shortages: description and trends from 2012 to 2018: an observational retrospective study

International audienceObjectives The aim was to provide figures for drug shortages in France and describe their characteristics, causes and trends between 2012 and 2018. Methods Data from the national reporting system from the Agency of Medicine and Health Product Safety (ANSM) was analysed. This database contains information regarding effective and predicted shortages of major therapeutic of interest drugs (ie, drugs whose shortage would be life-threatening or representing a loss of treatment opportunity for patients with a severe disease) which are mandatory reported by marketing authorisation holders to the ANSM. Data are presented as numbers or percentages of pharmaceutical products (ie, the product name and its formulation) reported on shortage between 2012 and 2018. Results There were 3530 pharmaceutical products reported on shortage during the period, including 1833 different active substances. Drugs on shortage were mostly old products (63.4%) with national marketing authorisation procedures (62.8%), as well as injectable and oral forms (47.5% and 43.3%, respectively). Anti-infectives for systemic use ranked first (18%), followed by nervous and cardiovascular system drugs and by antineoplastic and immunomodulating agents (17.4%, 12.5% and 10.4%, respectively). The number of reported shortages presented a fourfold increase between 2012 and 2018 and a sharp rise in 2017 and 2018, along with a rise in the number of active substances on shortage. The therapeutic classes concerned remained similar over time. Manufacturing and material supply issues were the main reported reasons for the shortage each year (30%) and there was an overall rise of pharmaceutical market reasons. Conclusion Drug shortages were increasingly reported in France. Preventive measures should specifically target the products most on shortage, in particular old drugs, injectable, anti-infective, nervous system and cardiovascular system drugs as well as antineoplastic and immunomodulating agents

Real-world evidence (RWE): A challenge for regulatory agencies discussion of the RWE conference with the network of the european medicine agencies, patients, and experts

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Biosimilaires : de la technique au médicoéconomique

Le médicament biosimilaire (BS) correspond à un médicament biologique déclaré comme similaire à un médicament biologique de référence et dont le plan de développement inclut des études de comparaison par rapport à la référence, afin de confirmer la similarité du produit au niveau qualité, sécurité préclinique, et profil d’efficacité et de sécurité cliniques dont l’immunogénicité. Les biosimilaires (BS) sont différents des génériques, tant par leur complexité moléculaire que par leur réglementation. Ils représentent des enjeux économiques considérables avec l’expiration dans les 5 prochaines années des brevets de nombreux biomédicaments couvrant des aires thérapeutiques majeures comme la cancérologie, la rhumatologie ou la gastroentérologie, qui représentent des dépenses importantes pour l’Assurance maladie. La table ronde (TR) a émis des recommandations pour que l’arrivée des BS soit un succès, en s’appuyant sur le médecin prescripteur comme acteur de l’information et de la confiance, en mettant en place un suivi des patients traités par biomédicaments, et en accélérant l’accès au marché de leurs biosimilaires. Abréviations : voir en fin d’article

Biosimilars: from Technical to Pharmacoeconomic Considerations

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