1
Scientific article
Use of Spanish registries for the generation of scientific evidence: ENEIDA and BIOBADASER
These two observational studies aim to generate evidence about biosimilars and their use in clinical practice. The first one studies the safety and efficacy of the switch between intravenous infliximab and subcutaneous biosimilar infliximab in the treatment of inflammatory bowel disease. The second article focuses on the comparison in terms of safety and efficacy between reference etanercept and adalimumab and their biosimilars in the treatment of rheumatic diseases.
In addition to not finding significant differences between these biosimilars and their respective reference drugs, both studies are especially relevant given that they use Spanish databases, promoted by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) and the Spanish Society of Rheumatology (SER). This demonstrates the enormous potential of this type of registry and the large volume of clinical data they contain and that could be exploited, as well as the good work of scientific societies in Spain.
Journal of Crohn's and Colitis / The Journal of Rheumatology
https://www.jrheum.org/content/early/2024/06/24/jrheum.2024-0001
2
Report
Annual Report of the National Health System 2023
A new edition of the SNS annual report has been published, which includes data on the state of health of Spanish society, its social determinants and different aspects of the healthcare system in 2022. Regarding biosimilars, these medicines have accounted for 9,9% of total hospital expenditure on medicines.
Along with this general report, the monographic report “Pharmaceutical Provision in the National Health System, 2023” is presented, which compiles and expands the consumption data for 2021 and 2022, both for biosimilars and other medicines. In Tables 29 and 30, a general progression can be observed in the penetration and number of packages of biosimilars consumed, both for those for hospital use, with adalimumab as the most consumed drug in PVL, and for those dispensed in pharmacies, where enoxaparin sodium remains the leading molecule.
Ministry of Health
https://www.sanidad.gob.es/estadEstudios/estadisticas/sisInfSanSNS/tablasEstadisticas/InfAnSNS.htm
3
Scientific article
Patient preferences for adalimumab in inflammatory bowel disease: a nationwide GETAID study
This cross-sectional study, carried out by the “Groupe d'Etude Therapeutique des Affections Inflammatoires du tube Digestif” in France, reflects the results of a survey completed by 941 patients with inflammatory bowel disease spread across 45 centres. The aim of the survey was to assess the level of satisfaction of patients treated with adalimumab, both biosimilar and reference. The overall level of satisfaction was 8,5 (on a scale of 10), with several biosimilars among the highest scores, something that is repeated when assessing the subcutaneous injection device. This high level of satisfaction is essential to establish the trust of doctors and patients in biosimilars, thus encouraging their adoption and avoiding the possible nocebo effect.
Therapeutic Advances in Gastroenterology
https://journals.sagepub.com/doi/10.1177/17562848241265776
4
Video
Biosimilars in multiple sclerosis: Natalizumab
The first video tip of the new season of “Biosimilars and Pharmacy” is now available, this time focusing on the use of biosimilars in the treatment of multiple sclerosis. The video explains the disease and its symptoms, and discusses natalizumab, the biosimilar alternative currently available that allows a greater number of patients access to this biological therapy.
CGCOF, Medicine Television and BioSim
https://www.youtube.com/watch?v=Qv_x5ZUQl6o
5
Scientific article
Biosimilar approval pathways: comparing the role of five regulatory agencies
The article compiles the different approaches to the approval of biosimilars by regulatory agencies in the European Union, the United States, Canada, the United Kingdom and Australia. As of May 2024, the European Medicines Agency is the reference agency for approved biosimilars, with 101. Of all the regulatory bodies mentioned, the main aspects that may limit the adoption of biosimilars are compared: regulatory requirements, extrapolation of indications, market exclusivity of reference medicines and positions regarding exchange and substitution, and the need to create a regulatory framework that promotes the use of biosimilars with the aim of having accessible biological alternatives for patients is highlighted.
