Biosimilars approved in Argentina

Biosimilars/General | Posted 11/03/2022 post-comment0 Post your comment

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 logo V13E03

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.

Related articles
The biosimilars market in Latin America: a summary

Similar biotherapeutic products approved and marketed in Latin America

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. 

  

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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