Biosimilars have been marketed in the European Union (EU) for 13 years. Due to uncertainties about substitutability and interchangeability, their commercialization has been criticised.
According to Vázquez Vega, former Spanish Under-Secretary of Health and Consumer Affairs, it is desirable that pharmaceutical industry's revenues grow if at the same time it invests in innovation and development of new drugs, and he further explains that ‘without growth there is no research, without research there is no innovation, and without innovation there is no room for progress in the industry or for the improvement of drugs’.
Biosimilars started to be marketed on the European market in 2006. By February 2021, 69 biosimilars have been authorised in the EU through the centralized procedure . In Spain, only 38 biosimilars have been registered, of which six have been authorized through the national procedure . In the coming years, more biosimilars are expected to be authorized due to the imminent expiry of the patents of reference biological medicines and the possible authorization of marketed biological medicines approved by the regulatory authorities.
As Günter Verheugen, Vice President of the European Commission for Enterprise and Industry, stated, ‘biosimilars offer new opportunities both for the growth of our own industry and for the control of our countries' health expenditures’.
Biosimilars help the financial sustainability and all stakeholders in the healthcare system:
- They contribute to increase competition between pharmaceutical companies in a number of regulatory areas, such as price control.
- Favouring the marketing of biosimilars lowers the price of reference medicines.
- Patients benefit from the emergence of new forms and routes of administration.
- The reduced price of biosimilars allows more patients to have access to treatment.
- Public administrations can rationalise pharmaceutical spending without harming patients.
Experts estimated that the entry of biosimilar medicines into the market resulted in savings of more than Euros 478 million during 2009–2016.
Readers interested to learn more about biosimilars in Europe are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Policy recommendations for a sustainable biosimilars market: lessons from Europe
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Readers interested in contributing a research or perspective paper in Spanish and/or English on policy and biosimilars to GaBI Journal – an independent, peer reviewed academic journal – please submit your manuscript here.
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LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.
View this week’s headline article: La MHRA del Reino Unido actualiza su directriz para conceder licencia de biosimilares
Browse the news in the Latin American Forum!
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LATIN AMERICAN FORUM
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.
Vea el artículo principal de esta semana: La MHRA del Reino Unido actualiza su directriz para conceder licencia de biosimilares
Explore las noticias en el Foro Latinoamericano!
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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. Noguera Peña A, del Castillo Rodríguez C. Equilibrio entre la innovación y el gasto público sanitario. El caso particular de los medicamentos biosimilares. Revista Derecho del estado n.º 48, enero-abril de 2021, pp. 273-296.
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