- These medicinal products are similar to their counterparts in terms of efficacy, safety and quality, and are backed by comprehensive clinical studies
- Cancer treatments are some of the ones that benefit the most from this medical innovation, and at a lower price for Health Authorities
Treatments with biosimilar medicinal products mean that more patients are able to access medical innovations earlier with the highest efficacy, safety and quality conditions, while the healthcare expenditure is reduced by 40%, because the national patents on the original biological medicinal products have expired, and they are approved and produced under the same standards as their counterparts.
Affordable prices in medical treatments for serious diseases in hospitals – mainly oncological, such as breast cancer, colon cancer, lymphoma, as well as autoimmune diseases, diabetes and others – with financing by the Public Health Authorities make it possible for governments to help reach more patients and improve their quality of life living with the disease thanks to these innovative medicines, products to which they would not have access in any other way.
A biosimilar is a biological drug equivalent to the original medicinal product in terms of efficacy and safety: its active substance is essentially the same biological substance. The active ingredients for biosimilar medicinal products for oncology are biosimilar monoclonal antibodies. “Their use is highly beneficial to patients’ quality of life, with lower healthcare costs ranging from 25% to 40% less. This results in improved healthcare budget management and sustainability. The hegemonic control of pharmaceutical companies over treatment of these diseases is broken, which creates greater competition,“ explains Eduardo Cioppi, a member of the mAbxience board of directors, a company that specialises in the innovation, development, manufacture and marketing of biosimilar drugs.
In particular, the price of traditional medicinal products for cancer treatment has increased progressively, doubling in the last ten years*, which has made it increasingly difficult for public health systems to gain access to them. “Biosimilar medicinal products are a valid alternative for patients with very delicate conditions and are completely safe. These drugs are subject to the same requirements and clinical study controls as the original medicinal products. Biosimilarity must be demonstrated extensively according to the regulatory agency guidelines”, confirms Mr Cioppi, explaining that biosimilars may entail lighter clinical evidence due to the great efforts in the early stages of the research already made with reference products. The concept of biosimilarity is heavily supported by characterisation and comparability.
One example of the immense possibilities of biosimilar medicinal products for the sustainability of public health systems and access to therapeutic innovation are the Bevacizumab and Rituximab biosimilars, mainly used in oncology for lung cancer, colon cancer and lymphomas. Both were developed by mAbxience in line with the most demanding local and international regulations, with multi-centre and international clinical studies that establish that the final product is equivalent in efficacy and safety to the original product.
Argentina has been an example of how these two innovative treatments, approved by the Argentinian Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT [National Administration for Drugs, Foods and Medical Devices]), have already benefited over 10,000 cancer patients: since November 2014, rituximab biosimilar, Novex® has been marketed in public healthcare. More than 21,100 cycles have been administered to patients with no adverse effects. Since November 2016, more than 24,000 cycles of bevacizumab biosimilar, Bevax®, have been marketed with no adverse effects reported other than those reported with the original medicinal product and a savings of more than 100,000 US dollars per year for the Argentinian public health system.
“Biosimilars offer a great opportunity to help control healthcare costs, contributing to the sustainability and efficiency of healthcare systems, all the while allowing a larger number of patients to benefit from treatments, or to do so even earlier”,concludes Mr Cioppi.
*“Los medicamentos para el cáncer: altos precios y desigualdad”, Informe 2018 de la alianza de organizaciones que luchan para defender y promover el acceso universal a los medicamentos como parte indispensable del derecho a la salud [“Cancer medications: high prices and inequality”, 2018 Report from the alliance of organisations that fight to protect and promote universal access to medicines as an essential part of the right to health] (Salud por Derecho [Right to Health], Médicos del Mundo, AAJM, OMC, OCU, SESPAS, CECU). http://noslajuegan.org/