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.
Ten best-selling biosimilars in Brazil in 2023
Biosimilars/General | Posted 01/10/2024 0 Post your comment
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
LATIN AMERICAN FORUM View the latest headline article: Nuevos hallazgos de semaglutida en el tratamiento de la hidradenitis supurativa Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
FORO LATINOAMERICANO Ver el último artículo de cabecera: Nuevos hallazgos de semaglutida en el tratamiento de la hidradenitis supurativa !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. |
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.
Research
Uzpruvo/AVT04 biosimilar in profile
Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Related content
Biologicals and biosimilars available for IBD in Canada
Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
SBR issues consensus on interchangeability of reference products and biosimilars
Innovative direct purchase agreement sees adalimumab biosimilar prices slashed
Comments (0)
Post your comment