In Brazil, the regulatory body for the approval of biologicals is the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA), which is linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory.
The Agency was created by the Law 9.782 of 26 February 1999. The Agency’s mission is to protect and promote public health, guaranteeing the health products’ safety and participate in building its access. The Agency is led by a Collegiate Board of Directors, composed by five members and it is executed by institutions of the direct and indirect Public Administration of the Union, the States, the Federal District and the Municipalities, that execute regulatory activities, normalization, control and inspection in the health surveillance zone.
In Brazil, the legal framework that approves the marketing of biological products and biosimilars is the Resolution 55 (of 16 December 2010).
Remsima (CT-P13), an infliximab’s biosimilar, was the first biosimilar approved by ANVISA in April 2015.
To date, ANVISA has approved 30 biosimilars [1] within the product classes of: 1) insulin; 2) monoclonal antibodies; 3) tumor necrosis factor (TNF) inhibitor; 4) human growth hormone; 5) anticoagulants and heparins; 6) granulocyte colony-stimulating factor for use in Brazil, see Table 1.
| Table 1: Biosimilars approved by ANVISA
|
| Product name
|
Active substance
|
Therapeutic area
|
Authorization date
|
Manufacturer/Company name
|
| Admelog
|
insulin lispro
|
Diabetes
|
Sep 2018
|
Sanofi
|
| Amgevita
|
adalimumab
|
Adults:
Axial spondyloarthritis
Crohn's disease
Hidradenitis suppurativa
Plaque psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Children (>13 years):
Polyarticular juvenile rheumatoid arthritis
Children (>6 years):
Crohn's disease
|
Apr 2019
|
Amgen
|
| Basaglar
|
insulin glargina
|
Diabetes
|
May 2015
|
Lilly France Fegersheim/Eli Lilly
|
| Bio-Manguinhos Etanercepte
|
etanercept
|
Ankylosing spondylitis
Non-radiographic axial spondylitis
Plaque psoriasis
Psoriatic arthritis
Rheumatoid arthritis
|
Sep 2017
|
Fundação Oswaldo Cruz
|
| Brenzys (SB4)
|
etanercept
|
Ankylosing spondylitis
Non-radiographic axial spondylitis
Plaque psoriasis
Psoriatic arthritis
Rheumatoid arthritis
|
Dec 2017
|
Catalent Belgium SA/ Patheon Italia SpA/Samsung Bioepis
|
| Criscy
|
somatropine
|
Hypopituitarism
Turner's syndrome
|
May 2019
|
Cristália Produtos Químicos Farmacêuticos Ltda
|
| Erelzi
|
etanercept
|
Paediatric plaque psoriasis
|
Dec 2017
|
Sandoz
|
| Fiprima
|
filgrastim
|
Neutropenia
|
Oct 2015
|
Eurofarma Laboratórios
|
| Glargilin
|
insulin glargine
|
Diabetes
|
Jul 2018
|
Gan & Lee Pharmaceuticals
|
| Glatus
|
insulin glargine
|
Diabetes
|
Nov 2019
|
Aspen
|
| Heparinox
|
enoxaparin sodium
|
Acute myocardial infarction with ST segment elevation
Acute myocardial infarction without ST segment elevation
Deep vein thrombosis
Thrombus prevention unstable angina
|
Apr 2019
|
Nanjing King-friend Biochemical Pharmaceutical Co Ltd/Cristalia
|
| Herzuma
|
trastuzumab
|
Early breast cancer
Metastatic breast cancer
Metastatic gastric cancer
|
May 2019
|
Celltrion Inc
|
| Hyrimoz
|
adalimumab
|
Adults:
Axial spondyloarthritis
Crohn's disease
Plaque psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Suppurative hidradenitis
Ulcerative colitis
Uveitis
Children:
Arthritis-related disorders
Crohn's disease
Polyarticular juvenile idiopathic arthritis
Uveitis
|
Nov 2019
|
Sandoz
|
| Insuliv R
|
human insulin
|
Diabetes
|
Mar 2018
|
Biocon Limited
|
| Kanjinti
|
trastuzumab
|
Metastatic gastric cancer
Metastatic breast cancer
Early breast cancer
|
May 2019
|
Actavis Italy SpA
|
| Mvasi
|
bevacizumab
|
Cervical cancer
Colorectal cancer
Epithelial ovarian cancer
Metastatic and/or advanced breast cancer
Metastatic colorectal cancer
Metastatic renal cell carcinoma
Non-small cell lung cancer
Primary peritoneal cancer
Uterine cancer
|
Feb 2019
|
Amgen
|
| Ontruzant
|
trastuzumab
|
Early breast cancer
Metastatic gastric cancer
Metastatic breast cancer
|
May 2019
|
Patheon Italia SpA
|
| Remsima (CT-P13)
|
infliximab
|
Ankylosing spondylitis
Crohn's disease
Fistulizing Crohn's disease
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
|
Oct 2016
|
Celltrion Inc
|
| Renflexis
|
infliximab
|
Ankylosing arthritis
Crohn's disease
Plaque psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
|
Jul 2018
|
Biogen Denmark Manufacturing ApS/Patheon Italia SpA/ Samsung Bioepis
|
| Riximyo
|
rituximab
|
Granulomatosis with polyangiitis
Leukaemia
Microscopic polyangiitis
Non-Hodgkin's lymphoma
Rheumatoid arthritis
|
Apr 2019
|
Lek pharmaceuticals d d/Sandoz
|
| Ruxience
|
rituximab
|
Granulomatosis with polyangitis
Leukaemia
Microscopic polyangiitis
Non-Hodgkin's lymphoma
Rheumatoid arthritis
|
May 2020
|
Wyeth
|
| Trazimera
|
trastuzumab
|
Breast cancer
Metastatic breast cancer
Metastatic gastric cancer
|
Dec 2019
|
Wyeth
|
| Truxima
|
rituximab
|
Granulomatosis with polyangitis
Leukaemia
Microscopic polyangiitis
Non-Hodgkin's lymphoma
Rheumatoid arthritis
|
Oct 2019
|
Celltrion Healthcare
|
| Visulin N
|
insulin isophane
|
Diabetes
|
Oct 2017
|
Biocon Limited
|
| Vivaxxia
|
rituximab
|
Chronic lymphocytic leukaemia
Non-Hodgkin's lymphoma
Rheumatoid arthritis
|
Jun 2019
|
Libbs Farmacêutica Ltda
|
| Xilbrilada
|
adalimumab
|
Adults:
Axial ankylosing spondylitis
Crohn's disease
Hidradenitis suppurativa
Plaque psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Uveitis
Children:
Crohn's disease
Juvenile idiopathic arthritis
Polyarticulararthritis related to enthesitis
Uveitis
|
May 2019
|
Wyeth
|
| Xilfya
|
infliximab
|
Ankylosing arthritis
Crohn's disease
Fistulizing Crohn's disease
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
|
May 2019
|
Pfizer Manufacturing NV
|
| Zarzio
|
filgrastim
|
Neutropenia
|
Oct 2016
|
Gp Grenzach Productions GmbH/Sandoz
|
| Zedora
|
trastuzumab
|
Early breast cancer
Metastatic breast cancer
Metastatic gastric cancer
|
Dec 2017
|
Biocon Ltd
|
| Zirabev
|
bevacizumab
|
Advanced primary peritoneal cancer
Cervical and/or colorectal cancer
Epithelial ovarian cancer
Metastatic colorectal cancer
Metastatic renal cell carcinoma
Non-squamous non-small cell lung cancer
Ovarian cancer
|
Mar 2020
|
Wyeth
|
Data updated on 14 January 2022.
Source: ANVISA
|
Hibor, a biomimic of bemiparin, is also authorised in Brazil for its use as an antithrombotic agent for the treatment of established venous thromboembolic disease.
Biomimics are intended copies, unregulated biologicals, biocopies, which cannot be considered biosimilars unless they have been reviewed and approved by the appropriate regulatory agencies in accordance with the international guidelines provided by the World Health Organization (WHO) for the approval of biosimilars [2].
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety, and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘biosimilars’ approved in Brazil might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
Related articles
Biosimilars approved in Chile
Biosimilars approved in Cuba
The biosimilars market in Latin America: a summary
Similar biotherapeutic products approved and marketed in Latin America
References
1. Ortiz-Prado E, Ponce-Zea J, Vasconez JE, et al. Current trends for biosimilars in the Latin American market. Generics Biosimilars Initiative Journal. (GaBI Journal). 2020;9(2):64-74. doi:10.5639/gabij.2020.0902.011
2. GaBI Online - Generics and Biosimilars Initiative. Glosario de términos principales [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 14]. Available from: www.gabionline.net/es/biosimilares/general/glosario-de-terminos-principales
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Source: ANVISA, GaBI Journal
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