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.

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.

Related articles
The biosimilars market in Latin America: a summary

Similar biotherapeutic products approved and marketed in Latin America

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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