1
Report
Proposal for the creation of the National Observatory of Biosimilar Medicines
The report promoted by BioSim and prepared by the Andalusian School of Public Health in collaboration with a group of experts is now available. It analyzes previous experiences launched in Spain and other European countries, and offers a roadmap for the creation of the Biosimilars Observatory in Spain, with the aim of providing useful information that facilitates decision-making at the national level. national and regional, regarding the promotion of the use of biosimilar medicines. Finally, a series of essential indicators are proposed to ensure its usefulness, the level of disaggregation of the published data, its accessibility, the frequency of its updating and some formats in which it could be presented, in addition to other elements that should be included.
Andalusian School of Public Health (EASP)
2
Press article
“Health will take advantage of upcoming regulatory projects to promote the biosimilar”
Last Friday, June 21, the Clara Campoamor Room of the Congress of Deputies hosted the training activity “Impact of biosimilars on sustainability and access”, promoted by the Spanish Association of Biosimilar Medicines, BioSim, and aimed at parliamentarians from the Health Commissions of the Congress, Senate and regional parliaments. Both during the inauguration, which included the participation of Javier Padilla, Secretary of State for Health, and Agustín Santos, president of the Health Commission of the Congress of Deputies, and throughout the rest of the training day, the emphasis was placed on the importance of biosimilars in the sustainability of the SNS and patient access to biological treatments, being, therefore, of vital importance to ensure their future presence in the market. During the closing, María del Mar San Martín, president of the Senate Health Commission, insisted on the importance of this type of conference: 'it is very valuable that parliamentarians are the target of these initiatives, as it will help us make informed decisions before the legislative projects on medicines that are currently being drafted and that will reach our hands in the coming months'.
diarypharma
3
Scientific article
Panorama of biosimilar medicines in Spain: market dynamics, policies, evidence-based perspectives and paths to a sustainable market
New article from the “Expert Opinion on Biological Therapy” in which Encarna Cruz, general director of BioSim, and Isabel del Río, deputy director of BioSim, reflect, among other topics, on the biosimilars market and adoption policies. In addition, they propose tools to promote the use of biosimilars and ensure the sustainability of the SNS, among which are the transition to value-based public purchasing with multiple contractors, the implementation of shared profit programs, educational initiatives for health professionals. and patients, the review of clinical practice guidelines after the release of a new biosimilar to the market, or transparency in the dissemination of data on the use of these medications at a regional level.
Expert Opinion on Biological Therapy
https://www.tandfonline.com/eprint/HHAW3UJS7AKJAWJKSTDM/full?target=10.1080/14712598.2024.2363229
4
Report
Annual report. Contribution of the European Medicines Agency to science, medicines and health in 2023
This new edition of the EMA annual report provides an overview of the Agency's activities to protect and promote public and animal health in the European Union. Between pages 51 and 53 of the report, a summary of the medicines positively evaluated by the EMA Committee for Medicinal Products for Human Use (CHMP) throughout 2023 is presented, including a total of 8 biosimilars for the therapeutic areas of oncology, hematology, rheumatology, neurology and ophthalmology. This represents the arrival of biosimilars of 5 new active ingredients (eculizumab, tocilizumab, ustekinumab, natalizumab and aflibercept) over the past year.
European Commission
https://www.ema.europa.eu/en/news/annual-report-highlights-progress-science-medicines-health-2023
5
Scientific article
Reviewing Health Technology Assessment Agencies' Approaches to Assessing the Value of Biosimilars: A Report from the ISPOR Special Interest Group
This article describes the current approaches of health technology assessment (HTA) agencies for evaluating the value of biosimilars. All information contained has been compiled by the ISPOR Biosimilars Special Interest Group based on a systematic review of published literature, which highlighted the limited guidance on how to assess the value of these medicines and on assessment techniques. appropriate economic analysis, and from different interviews with experts in health technology assessment (HTA) from Africa, America, Asia, Australia and Europe. After analyzing the different approaches in the different countries, the need to provide clearer guidance on when and how to perform HTA for biosimilars is highlighted, thus being able to take advantage of the generation of additional evidence that may represent elements of value related to forms of administration. , stakeholder preferences or adherence.
Value in Health
https://www.sciencedirect.com/science/article/pii/S1098301524000676
