As the largest country in South America, Brazil is an important market for the pharmaceutical industry, but the biosimilars still represent less than 2% of the total biological drug market in the country [1].
Mr Tiago Rocca, Strategic Partnerships & Business Development Manager at Instituto Butantan in São Paulo, Brazil gave a presentation entitled ‘Biosimilars in Brazil’ during the Word Biosimilar Congress Europe 2021.
The pharmaceutical market in Brazil had a revenue of R$85,9 billion in 2019, equivalent to US$17.2 billion, according to the Drugs Market Regulation Chamber (CMED) in 2022 [2].
CMED is the inter-ministerial agency responsible for the economic regulation of the drug market in Brazil, and the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA) plays the role of Executive Secretary of the Chamber. CMED sets drug price limits, adopts rules that stimulate competition in the sector, monitors sales, and applies penalties when its rules are not followed. It is also responsible for setting and monitoring the application of the mandatory minimum discount for public purchases.
The marketing of drugs by product type in 2019 from CMED/ANVISA according to the commercial reports sent by the companies is shown in Table 1 [2].
| Table 1: Marketing of drugs by product type in 2019
|
| Type of product
|
Companies
|
Products
|
Number of presentations with marketing
|
Number of active ingredients marketed
|
Sales invoicing (R$)
|
| New
|
113
|
1176
|
2797
|
1035
|
30.532.655.438,53
|
| Biologicals
|
75
|
305
|
613
|
202
|
21.840.136.916,23
|
| Biosimilars
|
153
|
2308
|
2380
|
895
|
17.238.652.065,17
|
| Generics
|
93
|
2335
|
2335
|
534
|
11.745.994.188,09
|
The turnover ranking by active ingredient of the two most traded substances are botulinum toxin A and trastuzumab with a turnover in excess of R$500 million. Other biologicals in the top 20 turnover ranking are bevacizumab, nivolumab, infliximab, rituximab, enoxaparin and pertuzumab [2].
Brazil was in 2010 the first Latin American country in regulating biosimilars. Then ANVISA published its Collegiate Board Resolution (RDC) 55/2010 for establishing the criteria for biosimilar approval in Brazil [3].
One year later, in 2011 the first biosimilar, somatropin, was launched. In 2015, the first biosimilar – filgrastim – was manufactured and launched in Latin America. In 2016 Infliximab was then launched. In 2019, Somatropin and Rituximab were manufactured and launched in Brazil. To date, more than 30 biosimilars have been launched although only a few of them are available for the population, and these are mainly focused on cancer treatments and rheumatic diseases [3].
Biological medicines consume around 40% of the federal public budget for the purchase of medicines in pharmaceutical assistance in the Unified Health System (Sistema Único de Salud, SUS), with rheumatoid arthritis being responsible for the greatest consumption of these resources [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Market outlook for biological medicines in Brazil 2016-2025 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 20]. Available from: www.gabionline.net/reports/market-outlook-for-biological-medicines-in-brazil-2016-2025
2. Rocca, T. Biosimilars in Brazil. World Biosimilar Congress Europe. Festival of Biologics. 9 November 2021, Basel, Switzerland.
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 20]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-brazil
4. GaBI Online - Generics and Biosimilars Initiative. Pharmaceutical market of biologicals and biosimilar medicines in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 20]. Available from: www.gabionline.net/reports/pharmaceutical-market-of-biological-and-biosimilar-medicines-in-brazil
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