Author Maritza Iglesias Galiano of the Universidad Peruana Cayetano Heredia in Lima, Peru conducted a study in 2021 on the management and implementation of the nomenclature of biological and biosimilar medicines in Argentina, information of which are being summarized below.
The two organizations responsible for the evaluation of biologicals/biosimilars in Argentina are:
1. the National Administration of Drugs, Food and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT), which is the body in charge of regulating the licensing of biologicals/biosimilars, and
2. the National Institute of Medicines, which is responsible for the technical evaluations of these products.
In 2011 and 2012, ANMAT published the different regulations governing drugs of biological origin, detailed in Table 1.
| Table 1: Summary of health regulations on biologicals published by ANMAT
| Provision 7075/2011
|| Establishes the requirements and demands for the registration of medicinal specialties of biological origin
| Provision 7029/2011
|| Approves the requirements and guidelines for the registration of medicinal specialties of biological origin whose qualitative-quantitative composition, therapeutic indication and proposed route of administration, have antecedents in other medicinal specialties of biological origin authorized and registered before ANMAT or other regulatory health authority of equivalent level to ANMAT (reference or comparator biological drug), of which there is evidence of effective marketing and sufficient characterization of its risk-benefit profile
| Provision 3397/2012
|| Approves the specific requirements for the submission of applications for authorization and registration of biological drugs and/or monoclonal antibodies obtained by recombinant RNA methods
ANMAT: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica.
This legislation establishes that biosimilars are not required to undergo the same clinical rigour as an innovator drug, whereby biosimilars are subject to comparative studies with the biological reference to demonstrate biosimilarity. These comparative studies include preclinical trials, as well as phase I, II and III studies, and the legislation establishes that for each potential indication of a biosimilar, scientific data supporting each indication will be required .
Regarding the nomenclature of biological and biosimilar medicines based on the health regulation, and as indicated in Table 2, ANMAT does not have established criteria and considers the same International Nonproprietary Name (INN) of the active substance for biological and biosimilar medicines.
| Table 2: Health regulation of the nomenclature of biologicals and biosimilars by ANMAT in Argentina
| Health regulation
|| Nomenclature criteria
Law 7729/2011 y
– Does not issue guidelines
– Maintains the same INN of the innovator biological medicine in authorized biological medicines
– Uses the term ‘biosimilar’
Data updated on 11 March 2022.
ANMAT: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; INN: International Nonproprietary Name.
On the other hand, ANMAT also does not provide any definition that includes the term 'biosimilar' in any of its provisions (laws 7025/2011; 7729/2011 and 3397/2012) that regulate drugs of biological origin. Therefore, and although currently the term ‘biosimilar’ is widely used in the specialized literature, in the Argentine regulation this word is not used in ANMAT's provisions .
There are currently 12 biosimilars approved in Argentina by ANMAT .
This article is the second in a series of articles on the nomenclature of biological and biosimilar medicines in several Latin American countries.
Regulations of the registration of biosimilars in Latin America
Definition of biological terms in Latin America
Argentinian gastroenterologist groups issued position statement on biosimilars use
Research, development and public production of pharmaceuticals in Argentina
Position of CAEME on biological and biosimilar drugs in Argentina
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1. Raimondo N, Echeverría C, Stengel F, et al. Biosimilares: consenso de expertos de la Sociedad Latinoamericana de Psoriasis (SOLAPSO) en Argentina. Medicina (Buenos Aires). 2018;78(4):272-81.
2. Iglesias Galiano M. Situación de la nomenclatura de biológicos y biosimilares en países de referencia, países de la región y del Perú propuestas de implementación. 2021.
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Argentina [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 11]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-argentina
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