Biosimilars approved in Chile

In Chile, the regulatory body responsible for the approval of biological medicines is the National Drug Agency (Agencia Nacional de Medicamentos, ANAMED), which is part of the Institute of Public Health of Chile (ISP), under the Ministry of Health.

ANAMED’s main functions include controlling authorized pharmaceutical, cosmetic and health products, whether manufactured locally or imported to be sold in the country, ensuring their quality, safety and efficacy; issue the necessary authorizations and provide registrations of pharmaceutical products and cosmetic; and control the distribution and dispensing of narcotic drugs and psychotropic substances, as well as their precursors, updating the databases of their use to comply with international agreements on the control of these substances.

On 21 August 2014, ISP approved Technical Standard No. 170 for the Health Registration of Biotechnological Products derived from recombinant DNA techniques, a regulation that is based on international criteria and that follows the World Health Organization’s (WHO) recommendations for the presentation and evaluation of the specific antecedents that they must be entered together with the applications for health registration of reference biotherapeutic products (RBP) and similar biotherapeutic products (SBP).

ISP defines biosimilars as medicines that have been shown to have quality, safety, efficacy and immunogenicity attributes similar to a reference biotherapeutic product.

To date, ANAMED has approved 14 biosimilars [1] within the product classes of: 1) monoclonal antibodies; 2) granulocyte colony-stimulating factor; 3) insulin; 4) tumour necrosis factor (TNF)-inhibitor for use in Chile, see Table 1.

Table 1: Biosimilars approved by ANAMED

Product name	Active substance	Therapeutic area	Manufacturer/ Company name
Alpha 2a	recombinant human interferon alfa-2a	Carcinoid tumour Hepatitis B and C Kaposi sarcoma Follicular lymphoma Malignant melanoma Multiple myeloma	Blau Farmacêutica SA
Basaglar	insulin glargine	Diabetes	Eli Lilly
Biofigran	recombinant human interferon alfa-2b	Carcinoid tumour Hepatitis B and C Kaposi sarcoma Follicular lymphoma Malignant melanoma Multiple myeloma	BioSidus SA
Blautrim	filgrastim	Neutropenia	Blau Farmacêutica SA
Filgen	filgrastim	Neutropenia	Bioproforma Bago SA
Foltran	filgrastim	Neutropenia	Lab Clausen
Heberon Alfa R	interferón humano recombinante alfa-2b	Carcinoid tumour Hepatitis B and C Kaposi sarcoma Follicular lymphoma Malignant melanoma Multiple myeloma	Herber Biotec
INF	recombinant human interferon alfa-2b	Carcinoid tumour Hepatitis B and C Kaposi sarcoma Follicular lymphoma Malignant melanoma Multiple myeloma	Laboratorios Bioprofarma SA
Interferon alfa 2b hm	interferón humano recombinante alfa-2a	Carcinoid tumour Hepatitis B and C Kaposi sarcoma Follicular lymphoma Malignant melanoma Multiple myeloma	Dong-A ST Co, Ltd
IorâLeukoCIM	filgrastim	Neutropenia	Centro de Inmunología Molecular (CIM)
Lioplin	filgrastim	Neutropenia	Dong-A ST Co, Ltd
Neutrofil	filgrastim	Neutropenia	Lab Pablo Cassara SRL
Remsima (CT-P13)	infliximab	Crohn's disease Psoriasis Psoriasic arthritis Rheumatoid arthritis Rheumatoid spondylitis Ulcerative colitis	Celltrion
Zarzio	filgrastim	Neutropenia	Sandoz
Data updated on 19 November 2021. Source: ANAMED [1].

Two biomimics are also authorized in Chile: -
1. Histocan, a biomimic of interferon alfa-2a for the treatment of hepatitis B and C, kaposi sarcoma, multiple myeloma, follicular lymphoma, carcinoid tumour and malignant melanoma
2. Reditux, a biomimic of rituximab, for the treatment of leukaemia, rheumatoid arthritis and lymphomas.

Interferon alfa-2a belongs to the non-licensed therapeutic class of interferon in Europe [2].

Biomimics are intended copies, unregulated biologicals, biocopies, which cannot be considered biosimilars unless they have been reviewed and approved by the appropriate regulatory agencies in accordance with the international guidelines provided by the World Health Organization (WHO) for the approval of biosimilars [3].

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

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 last week’s headline article: Regulación del registro de medicamentos biológicos en América Latina 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 la semana pasada: Regulación del registro de medicamentos biológicos en América Latina 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. Ortiz-Prado E, Ponce-Zea J, Vasconez JE, et al. Current trends for biosimilars in the Latin American market. Generics Biosimilars Initiative Journal. (GaBI Journal). 2020;9(2):64-74. doi:10.5639/gabij.2020.0902.011
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 19]. Available from: www.gabionline.net//Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Glosario de términos principales [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 19]. Available from: www.gabionline.net/es/biosimilares/general/glosario-de-terminos-principales

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Source: ANAMED, ISP