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].
Related articles
Brazil advances in follow-on biologicals/biosimilars approvals, trailing Europe
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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