In Argentina, the regulatory agency in charge of approving biological drugs is the National Administration of Drugs, Food and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT).
ANMAT's mission is to ensure efficacy, safety and quality in everything related to administration, guaranteeing health care, as well as the quality and sanitation of all products, processes and technologies consumed or used in medicine, human cosmetics and food.
ANMAT carries out registration, control, inspection and surveillance of medicines, cosmetics, diagnostic reagents, medical products, packaged foods, dietary supplements, additives, sweeteners and ingredients, household products, disinfectants and insecticides.
Through Provision N 3397/12 of 2012, the specific requirements for the submission of applications for authorization and registration of biological drugs and/or monoclonal antibodies obtained by recombinant DNA methods are approved.
To date, ANMAT has approved four biosimilars [1] within the product classes of: 1) monoclonal antibodies; 2) anticoagulants and heparins; 3) granulocyte colony-stimulating factor (G-CSF); 4) human growth hormone for use in Argentina, see Table 1.
| Table 1: Biosimilars approved by ANMAT
|
| Product name
|
Active substance
|
Therapeutic area
|
Manufacturer/Company name
|
| Bevax
|
bevacizumab
|
Advanced metastatic cancer
Cervical cancer
Colorectal cancer
Ovarian cancer
Lung cancer
Renal glioblastoma
|
Elea Sacifya Laboratory
|
| Fada enoxaparina
|
enoxaparin sodium
|
Thrombo embolism
Thrombosis
|
Fada Pharma
|
| Filgrastim Duncan
|
filgrastim
|
Febrile neutropenia
|
Duncan
|
| Filgrastim Interbelle/ Filgrastim Replens
|
filgrastim
|
Neutropenia
|
ELEA
|
| Heparinox
|
enoxaparin sodium
|
Venous thromboembolism
Deep vein thrombosis
Unstable angina
Acute myocardial infarction
Myocardial infarction
|
Denver Farma SA
|
| HHT
|
somatotropin
|
Growth hormone
|
BioSidus Sociedad Anonima
|
| Loparine
|
enoxaparin sodium
|
Pulmonary embolism
Clot prevention
Venous thromboembolism
Deep vein thrombosis
|
Rivero
|
| Neutropine
|
filgrastim
|
Neutropenia
|
Janseen Cilag Argentina (Gemabiotech)
|
| Omnitrope
|
somatotropin
|
Growth hormone
Renal insufficiency
Turner syndrome
|
Novartis Argentina SA
|
| Remsima (CT-O13)
|
infliximab
|
Ankylosing spondylitis
Crohn's disease
Rheumatoid arthritis
Psoriasis
Psoriatic arthritis
Ulcerative colitis
|
Celltrion
|
| Somactive
|
somatotropin
|
Growth hormone
Renal insufficiency
SHOX gene alterations
Turner syndrome
|
Gemabiotech
|
| Truxima
|
rituximab
|
Non-Hodgkin's lymphoma
Chronic lymphatic leukaemia
Rheumatoid arthritis
Granulomatosis with polyangiitis
Microscopic polyangiitis
|
Teva Tuteur
|
| Zomacton
|
somatotropin
|
Growth hormone
Turner syndrome
|
Ferring
|
Data updated on 11 March 2022.
Source: ANMAT.
|
There are currently 19 biomimics [1] approved in Argentina that belong to the therapeutic classes of interferon, insulin, anticoagulants and heparins, erythropoiesis-stimulating agents, G-CSF, follicle-stimulating hormone (FSH), monoclonal antibodies and chorionic gonadotropin hormone, see Table 2.
| Table 2: Biomimics approved by ANMAT
|
| Product name
|
Active substance
|
Therapeutic area
|
Manufacturer/Company name
|
| Bioferon
|
interferon ᾳ 2B
|
Carcinoid tumours with lymphatic affection
Carcinoid tumours with liver metastasis and carcinoid syndrome
|
BIoSidus Sociedad Anonima
|
| Densulin R
|
recombinant human insulin
|
Diabetes mellitus
|
Denver Farma SA
|
| Dilutol
|
enoxaparin sodium
|
Edema associated with congestive heart failure
Kidney or liver disease
|
Dr Lazar y CIA SA Quimica e Industrial
|
| Enoxanorth
|
enoxaparin sodium
|
Pulmonary embolism
Clot prevention
Venous thromboembolism
Deep vein thrombosis
|
Laboratorio Internacional Argentino SA
|
| Epogen
|
erythropoietin
|
Anaemia
|
Laboratorio Pablo Cassara SRL
|
| Filgen
|
filgrastim
|
Febrile neutropenia
|
Bioprofarma Bago SA
|
| Fostimon
|
follicle stimulating hormone
|
Stimulation of follicular maturation in infertile women
|
Laboratorios Buxton SA
|
| Gonacor
|
chorionic gonadotropin hormone
|
Stimulation of follicular maturation in infertile women
|
Laboratorios Ferring Sociedad Anonima
|
| Hemastin
|
erythropoietin
|
Anaemia
|
MR Pharma SA
|
| Ilcass
|
interleukin 2
|
Metastatic renal cells carcinoma
|
Laboratorio Pablo Cassara SRL
|
| Interferon Alfa 2B
|
interferon ᾳ 2B
|
Certain types of genital warts
Hairy cell leukaemia
Follicular lymphoma
Malignant melanoma
Kaposi's sarcoma caused by AIDS
|
Laboratorio Pablo Cassara SRL
|
| Lifecell
|
follicle stimulating hormone
|
Stimulation of follicular maturation in infertile women
|
Laboratorios Buxton SA
|
| Menopur
|
follicle stimulating hormone
|
Stimulation of follicular maturation in infertile women
|
Laboratorios Ferring Sociedad Anonima
|
| Molcass
|
molgramostim
|
Leukopenia
Neutropenia
|
Laboratorio Pablo Cassara SRL
|
| Neupogen
|
filgrastim
|
Neutropenia
|
Laboratorio Varifarma SA
|
| Neutrofil
|
filgrastim
|
Neutropenia
|
Laboratorio Pablo Cassara SRL
|
| Neutromax
|
filgrastim
|
Neutropenia
|
BIoSidus Sociedad Anonima
|
| Novex
|
rituximab
|
Follicular non-Hodgkin's lymphoma
|
Laboratorio Elea Sacifya
|
| Omatex
|
enoxaparin sodium
|
Venous thromboembolism
|
Laboratorios Phoenix Saic y F
|
Data updated on 11 March 2022.
Source: ANMAT.
|
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 Comments
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 ‘medicamentos biosimilares’ and ‘biomimics’ approved in Argentina might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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| LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Nomenclatura de biológicos y biosimilares en Argentina 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. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Nomenclatura de biológicos y biosimilares en Argentina !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.
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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 Mar 11]. Available from: www.gabionline.net/biosimilars/general/glosario-de-terminos-principales
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