1
Article
A strategic vision of biosimilar medicines: national – and European – approach to inspire other regions
BioSim participates in the first issue of the year of Ilaphar, the Ibero Latin American journal of Pharmacy of the Health System (peer-reviewed open access scientific journal) with this article that offers a review of the facilitating aspects of the growth and consolidation of the biosimilars market in Europe, and specifically in Spain. The first key aspect is to have a guaranteeing, solid and flexible regulatory framework, such as the entire set of guidelines created by the EMA at the beginning of this century in light of the imminent arrival of biosimilars. Also aligned biosimilar promotion policies (incentives, use objectives, public observatories, value-based public contracting) and especially all information and training campaigns aimed at health professionals and patients are considered essential elements for the promotion of these drugs. in other regions such as Latin America and the Caribbean.
Ilaphar
2
Public Data
Biosimilars in numbers
BioSim starts 2024 with a novelty on its website: it creates the Biosimilars in figures section to present, on a semiannual basis, and in graphic form, the data on the current situation of biosimilars in Spain and their evolution over time, since the most general data to the most detailed, based on official data from the Spanish Ministry of Health. The data is presented in packaging and allows us to know the evolution of the market in packaging (hospital, pharmacy office and total of the National Health System), the penetration by dispensing area (hospital, pharmacy office and total of the National Health System). and by active principle. This first publication corresponds to data from the first half of 2023.
biosim
https://www.biosim.es/medicamentos-biosimilares-en-cifras/
3
Article
Biosimilars: the key to access to health
Microbacterium, a collaborative platform to communicate science in a simple and accessible way, includes training in scientific communication and dissemination, as well as an extensive collection of articles for understanding the scientific world. On this occasion, they publish a short article with the key concepts about biosimilar medicines: what they are, how they are approved (illustrated with the example of the inverted pyramid) and the benefits they generate for society in terms of access and release of economic resources. .
microBacterium
https://microbacterium.es/biosimilares-la-clave-de-acceso-a-la-salud
4
Guide
Communication and information guide for nurses. Management of changes between similar biological medicines
This ESNO guide, which dates back to 2019, has been updated in 2022 after the EMA's positioning regarding the concept of interchangeability and has been gradually translated into other languages of the European Union. After English, Dutch, German, French and Italian, the Spanish version is now also available. This document offers examples of projects and good practices based on different specialties and pathologies. Its objective is to contribute to the safe use of and confidence in all biological medicines, including biosimilars. It also provides nurses with tools to apply change decisions in a clinical context and to address potential patient concerns, based on what they have learned from real experiences.
European Specialist Nurses Organization
https://esno.org/assets/files/Biosimilars%20Guideline%20V2%20ES.pdf
5
Scientific article
The impact of an evergreening strategy near patent expiration on biosimilar adoption and public healthcare costs: a case study on the introduction of a second form of administration of trastuzumab in the Netherlands
This work explores the evolution of the market share and costs derived from the launch and use of the subcutaneous variant of trastuzumab (SC) coinciding with the imminent introduction of the biosimilar of intravenous trastuzumab (BS-IV) in the Netherlands. These practices of extending the exclusivity period of the medicine are known as 'evergreening'. The introduction of the subcutaneous variant was gradual even though there was no price reduction, resulting in additional costs to society of €28 million. The entry of intravenous biosimilars into the market two years later meant a real reduction in prices and caused the use of the SC variant to decrease through various hospital policies such as treating only new patients with biosimilars and anticipating the arrival of new biosimilars by avoiding more use of the SC variant.
The European Journal of Health Economics
https://link.springer.com/article/10.1007/s10198-023-01648-w