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Argentinian guidelines for similar biological medicines Posted 03/05/2013

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.

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.

Editor’s comment
It should be noted that similar biological medicines approved in Argentina might not have been authorized following as strict a regulatory process as is required for biosimilars in the EU. EMA 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.

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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

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Source: ANMAT, EGA

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