Follow-on biologicals/biosimilars approved in Brazil: September 2025 update
Published on 06 October 2025
Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(2)
Abstract: |
Regulatory framework for biosimilars in Brazil
In 2010, Brazil established a legal framework for approving follow-on biological products through a comparability pathway under Resolution of the Collegiate Board of Directors (RDC) 55/2010 [1, 2], issued by the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA).
In June 2024, ANVISA published RDC 875 [3], amending the existing regulations (RDC 55/2010) for the registration of biological products. The new resolution introduces additional provisions for biosimilar registration via comparability development.
This regulation introduced the following innovations:
The possibility of acquiring the reference product abroad when it is not available on the national market, provided that the biosimilar registration applicant proves that the manufacturing site of the active pharmaceutical ingredient is the same as the one authorized in Brazil. Otherwise, a bridging study may be required in specific cases to ensure the product’s representativeness compared to the medicine duly authorized in Brazil.
The possibility of using an international reference drug, provided it is approved by an Equivalent Foreign Regulatory Authority (Autoridade Reguladora Estrangeira Equivalente, AREE). This allows the entry of new biosimilars even if there is no commercial interest in registering the new biological drug in the country or if has been permanently discontinued.
The possibility of waiving non-clinical studies, given the limitations of such studies in establishing product similarity, and in alignment with global efforts to reduce animal testing in the pharmaceutical industry.
The possibility of waiving comparative clinical studies, provided that high comparability, functionality, and characterization of the biosimilar candidate are demonstrated, along with a robust technical-scientific justification, subject to ANVISA’s evaluation.
This regulatory approach aligns with international standards set by the World Health Organization (WHO), the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) [4].
Terminology and approvals
ANVISA distinguishes between:
New biological product: a novel biological entity not previously registered.
Biological product (referring to the copy or follow-on products): a product containing an already-registered active substance [5].
This article serves as an update to the previous publication on follow-on biologicals and biosimilars approved in Brazil up to 2023. As of September 2025, ANVISA has approved a total of 67 follow-on biological/biosimilar products across various therapeutic categories. These products target 10 key biological pathways through mechanisms including:
- Antithrombotic activity, e.g., thrombin or factor Xa inhibitors
- B-cell depletion, e.g., anti-CD20 monoclonal antibodies like rituximab targeting B-lymphocytes
- Calcium/phosphate homeostasis modulation, e.g., recombinant parathyroid hormone (PTH) analogs like teriparatide that stimulate bone formation; and monoclonal antibodies like denosumab that inhibit bone resorption by binding to and neutralizing RANKL (receptor activator of NF-κB ligand), a key signal for osteoclast formation and activity.
- Complement system inhibition, e.g., anti-C5 agents like eculizumab to prevent terminal complement activation
- Cytokine inhibition for immune modulation, including:
– Targeting inflammatory cytokines, e.g., anti-TNF-α therapies (adalimumab, etanercept (fusion protein), infliximab) or anti-VEGF therapies (aflibercept (fusion protein), bevacizumab (with cancer indications), ranibizumab)
– Inhibiting immunoglobulin E (IgE), e.g., omalizumab to prevent IgE-mediated allergic responses - Growth hormone stimulation, e.g., somatropin for growth and body composition regulation
- Haematopoietic stimulation, e.g., filgrastim and pegfilgrastim for granulocyte colony-stimulating factors for white blood cell production
- HER2 receptor inhibition, e.g., trastuzumab biosimilars for HER2-positive tumours
- Insulin replacement, e.g., recombinant insulin analogs
- Interleukin pathway blockade, e.g., anti-IL-6 receptor like tocilizumab and IL-12/IL-23 inhibitors like ustekinumab for immune modulation
Table 1 summarizes the 21 active substances with approved biosimilars and their corresponding therapeutic indications. This expanded list reflects the growing diversification of biosimilars in the Brazilian market, offering broader treatment options across multiple disease areas.
Table 1: Active substances and therapeutic areas of approved follow-on biologicals/biosimilars in Brazil
However, one biosimilar, Sanofi Medley’s Admelog (insulin lispro), was withdrawn on 11 November 2024. This leaves a total of 66 follow-on biologicals/biosimilars approved for use in Brazil, as shown in Table 2.
Table 2: ANVISA approved follow-on biologicals/biosimilars*
Amgen, Samsung Bioepis and Sandoz lead with seven approved biosimilars, followed closely by Celltrion and Equilíbrio Comércio, Produtos Farmacêuticos Ltda., with six each. Pfizer ranks next with five approvals. Together, these six companies account for 57% of all biosimilars approved in the country.
Indication extrapolation and post-registration updates
Most approved follow-on biologicals/biosimilars in Brazil hold all indications of their reference products. Extrapolation is permitted if:
Comparability in safety and efficacy is demonstrated.
- The mechanism of action and target receptors are consistent across indications.
- The safety and immunogenicity profiles are well-characterized.
- The dosage form and route of administration match the reference product.
On 3 June 2024, Resolution RDC No. 876 was published in Brazil in the Official Journal of the Union (DOU) [6, 7], modifying the current regulations regarding the post-registration of biological products (RDC 413/2020). The purpose of the changes is, therefore, to optimize the process of filing petitions required to update the registration of biological products and to streamline their review by ANVISA [8].
Market impact and adoption
Brazil ranks as the fourth-largest global market for approved follow-on biologicals/biosimilars [9]. The top 10 follow-on biologicals/biosimilars by sales in Brazil in 2023 included [10]:
- Insulin
- Enoxaparin
- Somatropin
- Rituximab
- Trastuzumab
- Adalimumab
- Filgrastim
- Infliximab
- Etanercept
- Pegfilgrastim
A recent study highlighted the role of biosimilars in improving cancer survival rates and reducing treatment costs in low-and middle-income countries (LMICs), with Brazilian physicians recognizing their potential to enhance healthcare accessibility [11].
National Biosimilar Drug Day
On 6 January 2025, President Luiz Inácio Lula da Silva signed Law 15.087/25, designating December 16 as National Biosimilar Drug Day. The date commemorates the 2010 publication of ANVISA’s landmark resolution, which laid the foundation for biosimilar regulation in Brazil [12].
Editor’s comment
ANVISA does not distinguish between real biosimilars, follow-on products which are not real biosimilars, and innovator products. The products listed in Table 1 could be any of these.
Off-patent biologicals approved prior to the implementation of RDC 55/2010 do not meet the criteria for classification as biosimilars, as specified in the regulations outlined in RDC 55/2010.
This manuscript’s list of off-patent biologicals/biosimilars does not include medications that received approval before the implementation of RDC 55/2010.
The medicines listed in this manuscript, approved as biosimilars, followed the regulatory process outlined in RDC 55/2010 and complied with WHO guidelines.
Considering the global public health emergency caused by Sars- Cov-2, ANVISA published RDC 348/2020, which establishes extraordinary and temporary criteria and procedures for the registration and post-registration handling of medicines and biological products. This regulation allows for the inclusion of additional data and evidence to be submitted after registration through a commitment. However, applicants must still adhere to the specific rules for registering their regulatory category, as well as any applicable supplementary regulations.
Competing interests: Both Sílvia Helena Cestari de Oliveira and German Enrique Wassermann are employees of Cristália in Brazil.
Provenance and peer review: Not commissioned; internally peer reviewed.
Authors
Sílvia Helena Cestari de Oliveira, MSc
German Enrique Wassermann, PhD
Biotechnology Division, Cristália Produtos Químicos Farmacêuticos Ltda, Itapira-SP, Brazil
Author for correspondence: Sílvia Helena Cestari de Oliveira, MSc. Pesquisadora de Biotecnologia Senior – Divisão de Biotecnologia – Unidade I, Cristália Produtos Químicos Farmacêuticos Ltda, Highway Itapira-Lindóia, Km 14 – Ponte Preta, CEP: 13970-970 Itapira, SP, Brazil |
Disclosure of Conflict of Interest Statement is available upon request.
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