1
Scientific article
Use of Biosimilars: A systematic review of published positions and recommendations of health organizations and societies
This study, based on a systematic review of 25 articles published between 2009 and 2020, shows the progressive evolution in the positions and recommendations of different scientific societies and health organizations related to biosimilars in accordance with the growing scientific evidence and experience of use. It is highlighted how initially, in the oldest positions, there is little scientific support, especially in matters such as the extrapolation of indications and the exchange between reference medicine and biosimilar; However, it is observed that more recent articles have progressively based their positions on the available scientific evidence. On the other hand, this study shows relative unanimity in recommendations related to the prescription of biosimilars by commercial brand, automatic substitution and “multi-switching”, although it leaves the door open to possible updates given the more than likely evolution of the evidence. clinical and/or different regulatory aspects.
BioDrugs
https://link.springer.com/article/10.1007/s40259-024-00649-2#citeas
2
Press article
Use of biosimilar medicines financed by SNS
The Organization of Consumers and Users (OCU) echoes the “Study on the biosimilar market in the National Health System in Spain”, carried out by the Andalusian School of Public Health (EASP) and commissioned by BioSim, with the objective to support the authors' request to have biosimilar consumption data available. The OCU considers that, in addition to being public, these data, along with those corresponding to the rest of the medications included in the pharmaceutical provision of the SNS, must be accessible and harmonized in order to know the real situation and the economic and health impact. , carry out an analysis and implement the necessary policies that ensure the efficiency and sustainability of the system.
OCU
https://www.ocu.org/salud/medicamentos/noticias/biosimilares-sns
3
Scientific article
Policy measures and instruments to increase the acceptance of biosimilars in European countries: a systematic review
This systematic review attempts to compile the main policies implemented in different European countries that aim to promote the use of biosimilar medicines. After applying different criteria, 13 articles covering a total of 28 countries were included. Among the main policies, this article highlights tenders in the hospital field, the establishment of reference prices and the linking of prices between the reference medicine and biosimilars, which takes into account in some cases whether the biosimilar of a certain active ingredient whether or not it is the first on the market. On the other hand, other measures focused on demand are discussed, such as guides and recommendations aimed at prescribers, incentives and quotas or the creation of profit-sharing agreements. Once the review has been carried out, the importance of the European Medicines Agency (EMA) in guiding the most effective policies to increase the market share of biosimilars is emphasized.
Frontiers in Public Health
https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1263472/full
4
Video
Debate: Towards a national observatory for biosimilars?
The video of the debate that took place at the informative breakfast on the occasion of the presentation of the “Study on the biosimilar market in the National Health System in Spain” has already been published on YouTube. In this debate, titled “Towards a national observatory for biosimilars?”, moderated by Candela Calle, director of the Fundació Sant Francesc d'Assis, and which included the participation of César Hernández, general director of the Common Portfolio of Services of the SNS and Pharmacy, Jose María Casado, director of the Public Expenditure Evaluation Division of the AIReF, Félix Lobo, president of the Advisory Committee for Pharmaceutical Provision and professor emeritus of the Carlos III University of Madrid, and Isabel del Río Álvarez, deputy director of BioSim. In this debate, different points of view were shared about the importance of transparency and accessibility of consumer data. In addition, there was the intervention of Jaime Espín, from the Andalusian School of Public Health, who additionally presented the study in another video also available on the BioSim YouTube channel.
YouTube
https://www.youtube.com/watch?v=-0HuxTl1BMY
5
Scientific article
Persistence and safety of anti-TNF biosimilars compared to the originals in immune-mediated inflammatory diseases: an observational study in the French National Health Data System
In this observational study, using data from the “French National Health Data System”, patients who have started treatment with infliximab, etanercept or adalimumab are followed for one year. In total, 53% of patients started treatment directly with a biosimilar and, after comparing persistence and safety, no significant differences were found with those groups of patients who did so with the reference medication. The study even highlights a certain improvement in persistence in those patients treated with a biosimilar for some indication, depending on the active ingredient. In this sense, the study provides real-life evidence, both for those indications of the different biosimilars included in clinical trials and for those approved by extrapolation, corroborating the complete comparability of these anti-TNF drugs with their corresponding reference medications.