The main Brazilian regulatory framework for the registration of biologicals is the Resolution of the Collegiate Directorate RDC No. 55/2010. The National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA) stipulates that an originator/innovator/reference product is called a new biological product. A product that is not new or similar (such as biosimilars) is called a biological product and is defined as non-new.

According to the definition available on ANVISA website, biosimilars ‘are those biological products registered through development by comparability, which is the regulatory pathway used by a biological product or medicinal product to obtain registration, in which the comparability exercise in terms of quality, efficacy and safety between the product developed to be comparable and the comparator biological product was used’ [1].

Being among some of the highest cost medicines and also offering the best prospects for all market players, biologicals and biosimilars have attracted many pharmaceutical companies. This could generate a market ranging from the current R$820 billion (25% of total pharmaceutical sector revenues in 2016) to estimates of more than R$1.6 trillion by 2025, according to the Brazilian National Association of Private Hospitals (ANAHP 2018).

On the other hand, net spending for biological drugs in the US amounted to US$125.5 billion in 2018, an increase of 9.5% compared to the previous year. Spending on biosimilars, meanwhile, has doubled since 2017, but that figure still represents less than 2% of the total biological drug market in the country. Presenting forecasts for 2023, a report by IQVIA, a US multinational company that provides services for the combined health information technology and clinical research industries, estimates that net drug spending in the US will increase from US$344 billion in 2018, to US$420 billion, adding US$73 billion in new spending. Using 2018 as a baseline, the report states that biosimilars and generics have modest volume growth [2].

From these years of studies, improvements and developments, it has been observed that these new technologies, biologicals and their biosimilars, have brought improvements in health outcomes despite the budgetary impact they have entailed and the challenges that still exist for patients who benefit from their use.

In Brazil, in a study by Gabriela Mosegui, Cid Vianna and Thaís Catão showed that between 2015 and 2019 there was no saving of resources by the federal government with the purchase of similar biotherapeutic products for the treatment of cancer, however, working with different options like public purchases carried out through transparent bidding processes, where competition is encouraged, will expand public health access to more biosimilar treatments [3].

Related articles
Comparison of the cost of development of biologicals and biosimilars

Pharmaceutical market of biological and biosimilar medicines in Brazil

References
1. Gomes EB, Rosseto R, Pinheiro L. Desenvolvimento de biossimilares no Brasil. J Soc Tech Environ Science. 2016;5(1):31-42.
2. Tafla C. O papel dos biossimilares na saúde. [The role of biosimilars in health]. Portuguese.
3. GaBI online - Federal purchases of biological drugs for cancer in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 18]. Available from: www.gabionline.net/biosimilars/research/federal-purchases-of-biological-drugs-for-cancer-in-brazil

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