12 research outputs found
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
No abstract availabl
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