SEE ALL THE MONTHS

1

Video + Infographics

V National Biosimilars Day

On the occasion of the V National Biosimilars Conference, the full content of which can be viewed at this link, and in line with the themes of the two debate tables held there, BioSim has published three infographics. On the one hand, the main results of the market study of biosimilars in the SNS carried out by the Andalusian School of Public Health, and secondly, two infographics on the impact of biosimilars on patients' access to biological therapies (the result of the study multicenter retrospective observational study carried out by the Spanish Society of Hospital Pharmacy) and on the Early treatment concept and the role of biosimilars in shortening the time to access biological therapies.

biosim

https://www.biosim.es/v-jornada-nacional-de-biosimilares/

2

Scientific article

Do the results of clinical efficacy trials matter in regulatory decision making about biosimilars?

This article supports the theory, increasingly supported by experts, that sufficient evidence of biosimilarity can be obtained from a combination of analytical and functional tests and pharmacokinetic studies that can also generate immunogenicity data. The need for comparative efficacy studies for regulatory decision-making purposes when approving monoclonal antibodies and biosimilar fusion proteins is questioned.

BioDrugs

https://pubmed.ncbi.nlm.nih.gov/37831324/

3

video tip

Biosimilars in Diabetes

The fifth video within the 2nd season of the YouTube video advice channel on “Biosimilars and Pharmacy”. In this case, the biosimilar used in diabetes is addressed: insulin glargine. The indications, routes of administration and different devices currently available for patients with this chronic pathology of such high prevalence in our country are described. Its publication has coincided with the celebration of World Diabetes Day.

CGCOF, Medicine Television and BioSim

https://www.youtube.com/watch?v=paHQa4qKEoc

4

Report

Assessing the Biosimilar Void

This report provides an up-to-date perspective on the factors influencing the changing dynamics of the biologics market in Europe. Particular attention is paid to identifying classes of biologics that may not attract biosimilar competition, what they call 'the biosimilar gap'. The rationale for this report is that although biosimilar competition has been instrumental in Europe in generating savings and improving the availability of essential medicines for patients, the uncertainty associated with future loss of exclusivity events means that competition and therefore , savings, are not insured.

IQVIA

https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/assessing-the-biosimilar-void/iqvia-institute-assessing-the-biosimilar-void-10-23-forweb.pdf

5

Bell

Global Biosimilars Week

The International Generics and Biosimilars Association's (IGBA) 4th annual World Biosimilars Week was held from November 13 to 17, 2023, to raise awareness about the impact of biosimilars on cancer care.
Every day during the campaign week, BioSim, an entity participating in the awareness campaign, has focused on the themes established by IGBA with a daily infographic.

biosim

https://www.biosim.es/infografias-publicadas-durante-la-semana-global-de-los-biosimilares-2023/

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