mAbxience | Blog


Regulation of similar biotherapeutic products in Latin America varies widely among different countries and many of them have yet to introduce guidance for biosimilars, Latin America is moving towards increasing standards of regulation for these products. (1, 2)

During the last years ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) in Argentina, ANVISA (Agencia Nacional de Vigilancia Sanitaria) in Brazil y COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) in México have developed their own abbreviated regulatory pathways for similar biotherapeutic products, by merging World Health Organization (WHO) and European Medicines Agency (EMA) guidelines for biosimilars to suit their own political and economic needs. (3)

On 21 January 2013, the Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) announced the release of a new draft guideline for biologicals, including similar biotherapeutic products, in Colombia. (4)

By October 2017, 9 biosimilars have been approved in Latin America (3 of them monoclonal antibodies), corresponding to 4 active substances.

The EMA (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. (5)

In light of the foregoing, some countries such as Peru, through the Fulbright Commission and the Hipólito Unanue Institute Foundation (Fundación Instituto Hipólito Unanue, FIHU), have signed an academic cooperation agreement with the aim of training the Ministry of Health employees on international legislation in biological and biosimilar medicinal products. The programme includes theoretical and practical sessions given by internationally-recognised experts, in which the employees of the regulatory institute analyse case studies and perform queries to familiarise themselves with the best practices implemented in other countries. (6)

In addition, patient support resources have also been created such as the IAPO (International Alliance of Patients’ Organizations) in Latin America, a tool that contains up-to-date information based on scientific and technological evidence and regulatory information regarding biological and biosimilar drugs, as well as promotional advice for patient organisations. It is available in English, Spanish and Portuguese. (7)

In some countries, such as Argentina, it is mandatory to implement a post-marketing pharmacovigilance programme that includes the regular reporting of any adverse effects that may have arisen by means of an ICSR (Individual Case Safety Report).(8)

This post-marketing surveillance has shown a similar incidence of adverse effects after using rituximab biosimilar compared with the published data on the reference product.(9)


(1) Mysler E, Scheinberg M. Biosimilars in rheumatology: a view from Latin America. Clin Rheumatol. 2012;31:1279-80.

(2) Desanvicente-Celis Z, Caro-Moreno J, Enciso-Zuluaga M, Anaya JM. Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases. Biosimilars. 2013;3:1-17.

(3) GaBI Online – Generics and Biosimilars Initiative. Regulation of similar biotherapeutic products in Latin America []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. Available in:

(4) GaBI Online – Generics and Biosimilars Initiative. Colombia issues draft decree for registration of biologicals []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. Available in:

(5) GaBI Online – Similars biotherapeutic products approved and marketed in Latin America []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Disponible en:

(6) Comisión Fulbright y Fundación Instituto Hipólito Unanue  firman acuerdo de cooperación. 25 de Octubre de 2017. Available in:

(7) Medicamentos biológicos y biosimilares: Toolkit de información y promoción para organizaciones de pacientes. IAPO Américas (International Alliance of patients´organizations Americas). ​Available in:

(8) GaBI Online – Farmacovigilance of rituxmab in Argentina. []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 July 7]. Available in:

(9) 2131 Post-Marketing Surveillance with a Biosimilar of Rituximab (Novex®) in Argentina. Program: Oral and Poster Abstracts Session: 902. Health Services Research—Malignant Conditions: Poster I ASH 59th Annual meeting & exposition. Atlanta GA. December 9-12 2017