SEE ALL THE MONTHS

1

Scientific article

Real-life comparative analysis of original trastuzumab and its biosimilars: Safety, efficacy and cost-effectiveness

This study aims to provide evidence on the safety, efficacy and cost-effectiveness of using biosimilar trastuzumab in the treatment of HER2-positive breast cancer. To do so, large volumes of real-life data were analysed: clinical summaries of hospital discharges, costs and adverse events of patients after receiving treatment with one of the available biosimilar versions or with the reference trastuzumab. After analysing the data, the safety, efficacy and improved cost-effectiveness of biosimilar alternatives are demonstrated, with a 50,1% reduction in treatment costs per dose. In view of the results, the study highlights the importance of considering the potential of biosimilars when defining therapeutic strategies.

BioDrugs

https://link.springer.com/article/10.1007/s40259-024-00686-x

2

Video

Biosimilars in growth hormone deficiency: somatropin

“Biosimilars in growth hormone deficiency: somatropin” is the title of the second video tip of the new season of “Biosimilars and Pharmacy”. This new installment explains what growth hormone deficiency consists of and its symptoms, the existence of biosimilars to treat it and important aspects to take into account related to the administration and storage of the medication. An interesting fact is that somatropin was the first biosimilar approved in the European Union, in 2006.

CGCOF, Medicine Television and BioSim

https://www.youtube.com/watch?v=MtZe0hxGO20

3

Video

Biosimilars in Cancer Congress 2024

On October 12, the 2024 Biosimilars in Cancer Congress was held, organized by the CancerLife Foundation. The conference focused on the use of biosimilars in oncology, highlighting their potential to improve access to biological treatments, with the contribution of relevant clinical evidence. The deputy director of BioSim, Isabel del Rio, participated in the congress with a presentation focused on profit-sharing agreements, a very useful tool when facing the challenges of biosimilar adoption. During her speech, she showed some successful examples of this type of agreement in Europe and answered the question: why and how to propose a profit-sharing program in cancer?

CancerLife Foundation

https://www.youtube.com/watch?v=57ryLJhNbIM&t=1875s

4

Scientific article

The importance of real-world data in the safety assessment of biosimilars: A descriptive study of clinical practice in an Italian oncohematological population

The article demonstrates, thanks to real-life clinical data, the safety of biosimilar use, focusing on the use of rituximab in an Italian population of patients with oncohematological diseases, such as non-Hodgkin lymphoma and chronic lymphocytic leukemia. This study, which included 505 patients, analysed both the use of the reference drug rituximab and two of its biosimilars, specifically investigating the safety of switching between the reference drug and a biosimilar or between different biosimilars. The findings suggest that these switches do not significantly increase the risks of adverse reactions. Therefore, the study supports the safety of rituximab biosimilars and suggests that their use may help reduce costs without compromising patient safety in oncohematological pathologies.

cancers

https://www.mdpi.com/2072-6694/16/19/3419

5

Report

Highlights from the October 2024 Committee on Medicinal Products for Human Use meeting

Highlights from the October 2024 Committee on Medicinal Products for Human Use meeting
The Committee for Medicinal Products for Human Use of the European Medicines Agency, at its meeting in October, has recommended the approval of two new biosimilars of ustekinumab. If the European Commission grants both marketing authorisation, there will be nine biosimilars of ustekinumab approved in the European Union. In Spain, ustekinumab was the third most consumed medicine in PVL (Laboratory Sales Price) in hospitals in 2021, and the second in 2022, according to the latest available version of the “Report on Pharmaceutical Provision in the SNS”, so the arrival of biosimilars has an enormous impact on both savings and patient access to this biological treatment.

European Medicines Agency

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-october-2024