This article, the last in a series on the nomenclature of biological and biosimilar medicines in various Latin American countries based on the study by Iglesias Galiano M in 2021, analyses the management and implementation of the nomenclature of biological and biosimilar medicines in Peru [1].
The nomenclature of medicines is the assignment of a unique and universally accepted name for the active substance of the medicine, whether it is of chemical synthesis or, in this particular case, of biological origin.
In Peru, the regulations for the registration of biotechnological and biosimilar medicines were issued in 2016. Since then, Peru has implemented health regulations for the authorization of biological medicines from biotechnology through two registration or authorization pathways.
The first with full quality, safety and efficacy studies that correspond to innovative biological medicines. The second with comparability studies – which include full quality studies, and reduced safety and efficacy studies – through the similarity pathway granted by the biosimilar medicinal product status.
In Peru, the Health Authority – General Directorate of Medicines, Supplies and Drugs (Dirección General de Medicamentos, Insumos y Drogas, DIGEMID) – is responsible for the presentation of the Risk Management Plan for the marketing authorization of biological and biotechnological medicinal products; in addition to the periodic presentation of the Safety Reports with the evaluation of the benefit-risk balance established for each authorized medicinal product.
DIGEMID also regulates the requirements for the registration of biological medicines from biotechnology and biosimilars through Supreme Decrees Nos. 011-2016-SA, 013-2016-SA and 002-2021-SA [2].
Specifically, Supreme Decree No. 011-2016-SA amends Article 103 of the regulation for the registration, control and sanitary surveillance of pharmaceutical products, medical devices and medical products and approves the regulation governing the presentation and content of the documents required for the registration and re-registration of biological products: biotechnological products.
On the other hand, Supreme Decree No. 013-2016-SA approves the regulations governing the presentation and content of the documents required for the registration and re-registration of biological products that opt for similarity.
Finally, Supreme Decree No. 002-2021-SA aims to establish the regulatory provisions of Article 8 of Law No. 29459, Law on Pharmaceuticals, Medical Devices and Medical Products, as amended by Law No. 31091, to regulate the conditional health registration of medicines and biological products with phase III studies [3].
The regulatory requirements for biologicals are based on the criteria established by the reference health authorities, European Medicines Agency, US Food and Drug Administration and the recommendations of the World Health Organization regarding the quality, safety and efficacy of biological medicinal products. Table 1 contains a summary of the regulatory status and nomenclature criteria for biological and biosimilar medicines of the Peruvian Health Authority –
| Table 1: Health regulation of the nomenclature of biologicals and biosimilars by DIGEMID in Peru
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| Health regulation
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Nomenclature criteria
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Supreme Decree No. 011-2016-SA
Supreme Decree No. 013-2016-SA Supreme Decree No. 002-2021-SA
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– Does not issue a guideline
– Maintains the same INN of the innovator biological medicinal product in authorized biosimilar medicines
– Uses the term ‘biosimilar’
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Data updated on 20 May 2022.
DIGEMID: Dirección General de Medicamentos, Insumos y Drogas; INN: International Nonproprietary Name.
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The regulations issued by the Peruvian Health Authority DIGEMID in 2016 do not incorporate criteria regarding the handling of the nomenclature for biological medicines and biosimilars, using the same International Nonproprietary Name (INN) for the active substance in the innovator medicine and biosimilars.
In the current scenario of the regulation of biological and biosimilar medicines in Peru, it is necessary to implement criteria regarding the nomenclature of biosimilar medicines and the use of identifiers that allow them to be distinguished from the innovator medicine. In addition, the Pharmacovigilance System needs to be strengthened in order to increase the level and quality of adverse reaction reports to enable safety monitoring of biosimilar medicines entering the market.
As of October 2021, DIGEMID of the Peruvian Ministry of Health (Ministerio de Salud del Perú, 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 [4].
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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.
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References
1. Iglesias Galiano M. 2021. Situación de la nomenclatura de biológicos y biosimilares en países de referencia, países de la región y del Perú propuestas de implementación.
2. GaBI Online - Generics and Biosimilars Initiative. Peruvian guidelines for productos biológicos similares [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 20]. Available from: www.gabionline.net/guidelines/Peruvian-guidelines-for-productos-biologicos-similares
3. 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
3. 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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