1
Report
Horizon Scanning update for biosimilars
BioSim publishes the semiannual update of the Horizon Scanning report that shows the potential arrival on the market of new biosimilar medicines. By updating this document, it is intended to continue supporting the planning and decision processes of the different parties involved in pharmaceutical provision: optimization of purchasing processes, support in the review of positioning and therapeutic protocols once a biological active ingredient is subject to biosimilar competition, etc. In addition to incorporating new clinical trials of different biosimilar candidates, this update anticipates the arrival of new biosimilars of ustekinumab, denosumab, omalizumab and tocilizumab, which advance to the financing phase after having obtained marketing authorization from the European Commission. In the second part, a slight increase in the number of Spanish hospitals participating in clinical trials of different biosimilars included in the report is observed, mainly due to the start of several trials of pembrolizumab biosimilar candidates. In addition, this update is accompanied by a methodological note that describes and clarifies several concepts that facilitate its correct interpretation.
biosim
https://www.biosim.es/horizon-scanning/
2
Scientific article
Biosimilar monoclonal antibodies for cancer treatment
This comprehensive article provides an overview of biosimilars in the oncology field. Initially, after reviewing all aspects related to the development process of biosimilar medicines and different pharmacological aspects (structure, mechanisms of action, safety, pharmacokinetics and variability), all the analytical processes carried out during the approval of different biosimilars of bevacizumab. The analytical results show the enormous consistency in relation to the structural similarity with the reference medicine, something that ends up leading to clinical equivalence. Also included is a “horizon scanning” of oncological biosimilars currently in development. Finally, various challenges are raised that biosimilars face, such as the low profitability for developing companies, caused by enormous pressure on prices, or regulatory requirements, influencing the need to create an attractive market that ensures development. future of new biosimilars.
iScience
https://www.cell.com/iscience/
3
Guide
Considerations for demonstrating interchangeability with a reference product: Update
The FDA has published a draft update of its interchangeability guide where, based on extensive experience and current scientific evidence, it proposes that biosimilars that request the designation “interchangeable” no longer need to demonstrate, based on specific clinical trials, interchangeability, safety and effectiveness of the “switch” with the reference product. Despite not having a regulatory nature, once published, this new guide will facilitate the access and use of biosimilars in the United States. The FDA has approved several interchangeable biosimilars, confirming that they are as safe and effective as reference products, but believes that the need for these trials to grant “interchangeable” status has been a barrier to access in the US and They do not provide additional evidence. The agency has opened a consultation process, which will remain open until August 20 of this year.
Food and Drug Administration (FDA)
4
Scientific article
Clinical results of switching to biosimilar adalimumab in patients with rheumatoid arthritis: Spanish RESTART Registry
The article describes a multicenter retrospective study that uses data from the medical records of patients diagnosed with rheumatoid arthritis in Spain. Based on these real-life data, we seek to demonstrate the effectiveness and safety of the exchange, both between the original drug and a biosimilar of adalimumab, and between different biosimilars, with the treatment having to be maintained after the exchange for at least 6 months. After evaluation of 86 patients, only 3,5% of patients received biological treatment before adalimumab. After the completion of the study, the median of the clinical disease activity index (CDAI) and that of the DAS28-CRP, a fundamental variable to assess the activity of rheumatoid arthritis, remained at similar values, confirming the efficacy and safety of the biosimilar adalimumab after exchange.
Current Medical Research and Opinion
https://www.tandfonline.com/doi/full/10.1080/03007995.2024.2372295?af=R
5
Scientific article
Cost Savings Impact of Biosimilar Trastuzumab for the Treatment of HER-2 Positive Breast Cancer in a Hospital
This new article, which includes a study carried out in a Spanish hospital, demonstrates that, after the arrival of biosimilars of trastuzumab, the reduction in the cost of treating HER-2 positive breast cancer with this monoclonal antibody is reduced by more of 80%, also allowing greater access to these treatments. This study, together with another included in the same issue of the journal, which investigates the persistence in clinical practice of reference and biosimilar adalimumab in another Spanish hospital, reflects the growing interest of Spanish health centers in biosimilar medicines, recognizing them as the perfect tool to ensure the sustainability of the SNS and access to biological therapies.
