Biosimilars approved in Brazil

Biosimilars/General | Posted 14/01/2022 post-comment0 Post your comment

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.

ANVISA V22A14

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) Human growth hormone; 2) erythropoiesis-stimulating agent; 3) follicle-stimulating hormone; 4) granulocyte colony-stimulating factor; 5) insulin; 6) tumour necrosis factor (TNF) inhibitor; and 7) monoclonal antibodies 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 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

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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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