1
Scientific article
The value and holistic benefit of biosimilars in Europe: Parts 1 and 2
The first part of this study uses surveys and interviews with European healthcare stakeholders to explore the benefits and market dynamics of biosimilar medicines. Key findings include perceptions of increased access to innovative medicines and biological treatments.
The second part of the document analyzes, through a panel of experts, the importance of biosimilars in this improvement of access to biological medicines, emphasizing that savings is not the only benefit they offer. It introduces a market maturity framework with different stages that influence potential cost savings and patient outcomes. The document suggests adapting policy decisions to the specific needs of the market and the objectives of stakeholders (adapted purchasing processes, profit-sharing models, etc.) to maximize benefits, and highlights education as crucial to drive acceptance and understanding biosimilars.
Expert Review of Pharmacoeconomics & Outcomes Research
https://www.tandfonline.com/doi/full/10.1080/14737167.2023.2297926
https://www.tandfonline.com/doi/full/10.1080/14737167.2024.2310684
2
Public Data
Horizon Scanning
After the recent addition to the website of “Biosimilars in figures”, BioSim adds a new section that includes the semi-annual Horizon Scanning report, both in its Spanish and English versions. It is expected that this new document will serve as support in the planning and decisions of the different parties involved in pharmaceutical provision. The report's infographic shows the status of development and approval of biosimilars for those active ingredients that are estimated to lose exclusivity in the market before 2030, as well as other active ingredients with only one biosimilar currently on the Spanish market. On the other hand, it includes a summary of the clinical trials that have been carried out or are being carried out in Spain for the different biosimilars included in the report.
biosim
https://www.biosim.es/horizon-scanning/
3
Opinion article
The role of nurses in the use of biosimilar medicines
In this opinion article, Guadalupe Fontán, coordinator of the Research Institute of the General Nursing Council of Spain, highlights that the growing availability of biosimilar drugs improves patient access, reduces waiting times and expands their use in new therapeutic areas. easing the economic burden. However, it is considered that the lack of knowledge about these medications can limit these benefits, making it essential that health professionals, especially nurses, are well informed to guarantee educational support, both informative and training, to the patient when prescribing a new drug. treatment with biosimilar, guaranteeing adequate use and improving adherence to treatment. In this sense, she highlights the Guide to Biosimilar Medications for Nurses, prepared by BioSim and the General Nursing Council, as a reference document.
PharmaMarket
https://www.phmk.es/opinion/el-papel-de-las-enfermeras-en-el-uso-de-los-medicamentos-biosimilares
4
Report
Study on the biosimilar market in the National Health System in Spain
The first report is published that analyzes in depth the evolution of the biosimilars market in Spain with official consumption data, prepared by the Andalusian School of Public Health (EASP) in collaboration with BioSim. In it, it is concluded that Spain is in an intermediate position in Europe in relation to the market share of consumption of biosimilar medicines, so there is still room for improvement. However, the incorporation of biosimilars varies depending on the Autonomous Communities, as well as their scope of dispensing, with the pharmacy being the main area for improvement. Finally, because the improvement of pharmaceutical policies requires an evaluation based on systematic and publicly accessible data, this report highlights the need for standardized official data to understand the market for these medicines, crucial for authorities and health professionals, and must continue in in this sense the example of countries like Italy and Portugal.
Andalusian School of Public Health
5
Concept article
Conceptual document for the preparation of a reflection document on an adapted clinical approach in the development of biosimilars
This concept paper, published by the EMA, proposes a new clinical approach for biosimilar medicines, based on the growing knowledge and experience recapitulated over the years. This approach proposes reviewing the need for clinical efficacy trials for the approval of biosimilar drugs, especially for recombinant proteins and monoclonal antibodies, with a long history on the market. Thus, the EMA considers this review to be an important next step to maintain an attractive environment for the development of biosimilars while ensuring European patients' access to safe and effective biological products in the future.