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Ten best-selling biosimilars in Brazil in 2023

Biosimilars/General | Posted 01/10/2024 0 Post your comment

Biosimilars experienced a notable increase in sales during 2023, according to a study published by the Brazilian Association of Generic and Biosimilar Drug Industries (PróGenéricos). The data reveal that about 892,000 units of biosimilars were sold, representing a 43% growth compared to 2022.

In Brazil, biosimilars play a crucial role in improving access to essential treatments, reducing costs, and strengthening the health system in Brazil, while fostering competition and innovation in the pharmaceutical sector.

Table 1 presents a list of the 10 best-selling biosimilars in Brazil in 2023.

Brazil was the first Latin American country to regulate biosimilars in 2010. Then ANVISA, the regulatory body in charge of approving biological drugs, published its Collegiate Council Resolution (RDC) 55/2010 to establish the criteria for approval of biosimilars in Brazil [1].

Table 1: Top-selling biosimilars in Brazil by units in 2023

No.	Biosimilar/ Active ingredients	Therapeutic area
1	Insulina glargina	Diabetes
2	Enoxaparina sódica	Unstable angina Acute ST-segment elevation myocardial infarction Non-ST-segment elevation myocardial infarction Thrombosis prevention Deep vein thrombosis
3	Somatropina	Hypopituitarism Turner syndrome
4	Rituximab	Rheumatoid arthritis Granulomatosis with polyangiitis Leukaemia Non-Hodgkin lymphoma Microscopic polyangiitis
5	Trastuzumab	Breast cancer Metastatic breast cancer Metastatic gastric cancer
6	Adalimumab	Adults: Psoriatic arthritis Rheumatoid arthritis Axial spondyloarthritis Ulcerative colitis Crohn's disease Hidradenitis suppurativa Plaque psoriasis/ Uveitis Minors: Polyarticular juvenile idiopathic arthritis Crohn's disease Arthritis-related disorders Uveitis
7	Filgrastim	Neutropenia
8	Infliximab	Ankylosing arthritis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis Chron's disease Fistulizing Chron's disease
9	Etanercept	Psoriatic arthritis Rheumatoid arthritis Ankylosing spondylitis Non-radiographic axial spondylitis Plaque psoriasis
10	Pegfilgrastim	Neutropenia

The first biosimilar approved in Brazil by ANVISA was Remsima, a biosimilar of infliximab, in April 2015 [2].

To date, more than 52 biosimilars have been launched in Brazil. This number includes a variety of products to treat different diseases such as cancer, rheumatic diseases as well as autoimmune diseases such as diabetes [3].

According to PróGenéricos CEO Tiago de Moraes Vicente, the growth reflects the demand for more treatment alternatives for a wide range of other diseases.

Biosimilar medicines offer an effective and economical alternative to biotechnological medicines, with a rapidly expanding global market. However, Latin America still faces several significant challenges such as the need for greater education about biosimilars and modernizing regulatory frameworks. The continued development of policies and educational initiatives can help maximize the benefits of these medicines [4].

Guidelines for the regulation of biologicals, biosimilars and radiopharmaceuticals in Brazil

Nomenclature of biologicals and biosimilars in Brazil

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References
1. GaBI Online - Generics and Biosimilars Initiative. Brazilian market of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 1]. Available from: www.gabionline.net/reports/brazilian-market-of-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 1]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-brazil
3. Cestari de Oliveira SH. Follow-on biologicals/biosimilars approved in Brazil: May 2024 update. Generics Biosimilars Initiative Journal. (GaBI Journal). 2023;12(2):67-72. doi:10.5639/gabij.2023.1202.012
4. GaBI Online - Generics and Biosimilars Initiative. Challenges and progress in the registration of biosimilars in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 1]. Available from: www.gabionline.net/biosimilars/general/challenges-and-progress-in-the-registration-of-biosimilars-in-latin-america

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