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Peruvian guidelines for productos biológicos similares Posted 24/05/2013

Last updated: 10 January 2014

The regulatory body for approval of medicines in Peru is the Ministry of Public Health (Ministerio de Salud; MINSA).

The agency is responsible for the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products.

In Peru, a guideline for regulation of pharmaceutical products, including productos biológicos similares (similar biological products) as they are referred to in Peru, was published on 31 July 2011 and came into effect on 9 November 2012.

1. Overarching Guideline
This guideline covers all similar biological products:

Regulation for the registration, control and pharmacovigilance of pharmaceutical products, medical devices and sanitarian products
Decree N-016-2011-SA
Date: 9 November 2012
ftp://ftp2.minsa.gob.pe/normaslegales/2012/RM899_2012_MINSA.pdf

The guideline allows for an abbreviated licensing pathway for biosimilar biologic products through a similarity pathway and is based on the World Health Organization guidelines [1]. The guideline does not, however, define what is considered as a biosimilar biologic product.

According to the guideline (chapter V, article 107) applicants for the registration of similar biological products need to provide documentation that supports comparability with the reference product.

2. Draft Overarching Guidelines
MINSA also has the following draft guideline under public consultation:

Directiva Sanitaria que regula la presentación y contenido de los documentos requeridos en la inscripción y reinscripción de productos biológicos: Biotecnológicos (Health Directive governing the presentation and content of the documents required in the registration and re-registration of biological products: Biotechnology)
Date: 20 February 2013
End of consultation (deadline for comments): 22 March 2013
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Publicaciones/DocumentosConsulta/P08_2013-02-20_Directiva_biotecnologicos.pdf

This draft is intended to give more specific requirements for biologicals and similar biological products, and to complement the general requirements covered in Decree N-016-2011-SA.

Editor’s comment
It should be noted that productos biológicos similares approved in Peru might not have been authorized following as strict a regulatory process as is required for approval of 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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EU guidelines for biosimilars

References

1.  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.

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Source: MINSA

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