Peruvian guidelines for productos biológicos similares

Last updated: 20 May 2022

The regulatory body responsible for approving biological drugs in Peru is the General Directorate of Medicines, Supplies and Drugs (Dirección General de Medicamentos, Insumos y Drogas, DIGEMID) of the Peruvian Ministry of Health (Ministerio de Salud; MINSA).

DIGEMID is a technical regulatory institution whose fundamental objective is to ensure that the population has access to safe, effective and quality medicines and that they are used rationally.

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.

On 26 February 2016, the Supreme Decree No. 011-2016-SA was published, amending article 103 of the regulation approved by the Supreme Decree No. 016-2011-SA for the registration, control and health surveillance of pharmaceutical products, medical devices and medical devices, which had entered into force on 9 November 2012.

On the same date, the Supreme Decree No. 013-2016-SA was published, approving the regulations governing the presentation and content of the documents required for the registration and re-registration of biological products that opt for similarity route.

More recently, on 10 January 2021, the Supreme Decree No. 002-2021-SA approving the Regulation for the conditional health registration of medicines and biological products with phase III studies was published. Changes to medicines and biological products with conditional health registration continue to be classified according to the provisions of Supreme Decree No. 016-2011 and amendments [1].

General Guidelines

These guidelines cover all similar biological products:

1. Supreme Decree that amends Article 103 of the Regulation for the Registration, Control and Health Surveillance of Pharmaceutical Products, Medical Devices and Medical Products and approves the Regulation that controls the Presentation and Content of the Documents required for the Registration and Re-registration of Biological Products: Biotechnological Products
Decree No. 011-2016-SA
Date: 26 February 2016
https://cdn.www.gob.pe/uploads/document/file/193863/192588_DS_011-2016-SA.pdf20180904-20266-1t6xi1t.pdf

2. Regulations that regulate the Presentation and Content of the Documents required in the Registration and Re-registration of Biological Products that opt for the Similarity route are approved
Decree No. 013-2016-SA
Date: 1 March 2016
https://cdn.www.gob.pe/uploads/document/file/193866/192590_DS__013-2016-SA_.pdf20180904-20266-1rp9zcu.pdf

3. Supreme Decree that approves the Regulation for the Conditional Sanitary Registration of Medicines and Biological Products
Decree No. 002-2021-SA
Date: 10 January 2021
https://cdn.www.gob.pe/uploads/document/file/1539367/Decreto%20Supremo%20N°002-2021-SA.PDF

As of October 2021, DIGEMID of MINSA had approved two biosimilar monoclonal antibodies for use in Peru, Celltrion Flixceli (infliximab) and Clotinab (abciximab), in addition to two rituximab biomimics that are also authorized [2].

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 ‘productos biológicos similares/biosimilars’ approved in Peru might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Nomenclature of biologicals and biosimilars in Peru Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Nomenclature of biologicals and biosimilars in Peru !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

References
1. GaBI Online - Generics and Biosimilars Initiative. Peru issues decree for the registration of medicines and biological products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 20]. Available from: www.gabionline.net/guidelines/peru-issues-decree-for-the-registration-of-medicines-and-biological-products
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Peru [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 20]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-peru

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Source: DIGEMID, MINSA