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Biosimilars, innovation in the treatment of chronic disease

Biosimilars/General | Posted 27/08/2021 0 Post your comment

Biological therapies have meant a significant advance in the way of treating various chronic conditions such as cancer, rheumatoid arthritis, multiple sclerosis. However, they have brought with them high costs for health systems that have been channelled through supply programmes of this type of drugs, in the case of the Dominican Republic, through the High Cost Medicines Programme.

This programme, which supports some 8,000 patients, has an annual budget of Pesos 2,600 million, a significant figure which, in a context of health crisis, represents a clear challenge for the sustainability of the Dominican health system, considering that by 2021, 2% of gross domestic product (GDP) will be allocated to the health sector.

In this scenario, in recent months it has been proposed to weigh the introduction of biosimilar medicines, which are biological therapies with clinical effectiveness equivalent to reference medicines. In other countries in the region, biosimilars have led to a significant reduction in public health spending in those countries.

However, beyond their advantages in terms of reducing public health spending, experts ensure that biosimilar medicines are synonymous with innovation in treatment.

In the Dominican Republic, the Director of the High Cost Programme of the Ministry of Public Health, Dr Alfred Cruz, said that medicines for patients with high-cost treatments would not be in short supply until May 2021, but emphasized that the budget currently allocated for the acquisition of medicines is not sufficient.

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that biosimilars approved in the Dominican Republic might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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LATIN AMERICAN FORUM The brand-new section 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: México presenta nuevo decreto sobre regulación sanitaria Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. 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: México presenta nuevo decreto sobre regulación sanitaria Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.

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