Biosimilars, innovation in the treatment of chronic disease

Biosimilars/General | Posted 27/08/2021 post-comment0 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.

Health Budget 3

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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