Last update: 24 June 2022
The regulatory body for approval of medicines in Argentina is the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Foods and Medical Devices; ANMAT).
The agency was created in August 1992 by decree 1490/92 and it is responsible for the quality of drugs, foodstuff, medicinal products, diagnosis reagents, cosmetic products, dietary supplements and household cleaning products. The agency is also responsible for the authorization, registration, standardization, vigilance and monitoring of the products used in the human medicine, food and cosmetic fields.
ANMAT's mission is to ensure efficacy, safety and quality in everything related to the 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.
In Argentina, a draft guideline for biosimilars, or medicamento biológico similar (similar biological medicines) as they are referred to in Argentina, was issued in July 2008 by ANMAT [1].
Overarching Guideline
This guideline covers all similar biological medicines:
Registration and registry modification of biological medicinal products
Date: July 2008
The guideline allows for an abbreviated licensing pathway for similar biological medicines and is based on the European model [2].
The guideline defines a similar biological medicine as a medicinal product that has been shown, by similarity studies, to be similar in terms of quality, safety, and efficacy to a biological medicinal product taken as reference which has already been authorized by the health authority. The present definition is applicable to those products that may be broadly characterized, such as proteins obtained by recombinant DNA techniques and polypeptides and highly purified natural proteins.
Other regulatory provisions
In 2011, 2012 and 2019 ANMAT published different regulations on products/medicines of biological origin in Argentina:
1. Provision No. 9709/12
All medicines of biological origin, vaccines and radiopharmaceuticals, once registered in the Register of Medicinal Products (REM), must request the effective marketing authorisation to start their distribution and commercialisation.
Date of entry into force: 2 December 2019
https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-9709-2019-332648/texto
2. Provision No. 3397/12
The specific requirements for the submission of applications for authorisation and registration of biological medicinal products and/or monoclonal antibodies obtained by recombinant DNA methods are approved as set out in Annex I of this Provision.
Date of entry into force: 12 June 2012
https://www.argentina.gob.ar/sites/default/files/anmat_disposicion_3397-2012.pdf
3. Provision No. 7729/11
The requirements and guidelines for the registration of medicinal products of biological origin whose proposed qualitative and quantitative composition, therapeutic indication and route of administration have antecedents in other medicinal products of biological origin authorised and registered before this Administration or another Regulatory Health Authority (reference or comparator biological medicinal product), for which there is evidence of effective commercialisation and sufficient characterisation of their risk-benefit profile, are approved.
Date of entry into force: 14 November 2011
https://www.argentina.gob.ar/sites/default/files/anmat_disposicion_7729-2011.pdf
4. Provision No. 7075/11
The requirements and demands for the registration of medicinal products of biological origin are established.
Date of entry into force: 14 October 2011
https://www.argentina.gob.ar/sites/default/files/anmat_disposicion_7075-2011.pdf
These ANMAT provisions were established to update the criteria for the approval of biological medicines, in line with international standards to ensure their quality, efficacy and safety.
The term biosimilar is not used in any of the ANMAT provisions approved to date, always referring to these products as ‘medicamentos biológicos’ [3].
Biosimilars marketed since 2017 in Argentina include monoclonal antibodies such as rituximab, which is used to treat certain lymphomas and leukaemias, as well as rheumatoid arthritis. Also bevacizumab, which works against several cancers (including colon, lung, breast and kidney) by limiting the blood vessels that supply the tumours.
To date, ANMAT has approved for use in Argentina 13 biosimilars within the product classes of monoclonal antibodies, anticoagulants and heparins, granulocyte colony-stimulating factor and human growth hormone. In addition there are 19 approved biomimics belonging to the therapeutic classes of interferon, insulin, anticoagulants and heparins, erythropoiesis-stimulating agent, granulocyte colony-stimulating factor, follicle-stimulating hormone (FSH), monoclonal antibodies and chorionic gonadotropin hormone [4].
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 ‘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 article
The biosimilars market in Latin America: a summary
Colombian guidelines for productos bioterapéuticos similares
Similar biotherapeutic products approved and marketed in Latin America
Prospects for producing follow-on biological products in Brazil
EU guidelines for biosimilars
References
1. GaBI Online - Generics and Biosimilars Initiative. Global biosimilars guideline development – EGA’s perspective [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 3]. Available from: www.gabionline.net/Guidelines/Global-biosimilars-guideline-development-EGA-s-perspective
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars dilemma over reference products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 3]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilars-dilemma-over-reference-products
3. GaBI Online - Generics and Biosimilars Initiative. Nomenclature of biologicals and biosimilars in Argentina [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 24]. Available from: www.gabionline.net/policies-legislation/nomenclature-of-biologicals-and-biosimilars-in-argentina
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Argentina [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 24]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-argentina
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