In Ecuador, the regulatory body for the approval of biologicals is the National Agency for Regulation, Control and Health Surveillance (ARCSA).
ARCSA was created in August 2012 and is responsible for the regulation, technical control and sanitary surveillance of the following products: processed foods, food additives, medicines in general, nutraceutical products, biological products, processed natural products for medicinal use, homeopathic medicines and dental products; medical devices, biochemical and diagnostic reagents, and other hygienic products, pesticides for domestic and industrial use, manufactured in the national territory or abroad, for import, export, commercialization, dispensing and selling.
In 2019, ARCSA finalized the regulatory guidelines on biosimilars. The legal framework for biosimilar medicines is established according to the Regulation for Obtaining Health Registration of Biological Medicines No. 00385-2019, which includes biotechnological and biosimilar medicines. The purpose of this regulation is to regulate, control and monitor in the country the production and commercialization of biological medicines/drugs for human use and consumption, in order to guarantee their quality, safety and efficacy, as well as to establish the general procedure for obtaining the health registration.
ARCSA defines biosimilar drug as a biological drug that has demonstrated through the comparability exercise that it is similar to the reference biological drug in terms of quality, safety and efficacy.
To date, ARCSA has approved four biosimilars [1] within the product classes of: 1) erythropoiesis-stimulating agent; 2) granulocyte colony-stimulating factor (G-CSF); 3) tumour necrosis factor (TNF) inhibitor for use in Ecuador, see Table 1.
| Table 1: Biosimilars approved by ARCSA
|
| Product name
|
Active substance
|
Therapeutic area
|
Manufacturer/Company name
|
| Ior Leukocim
|
filgrastim
|
Neutrofilia
Neutropenia
|
Centro de Inmunologia Molecular (CIM)
|
| Remsima
|
infliximab
|
Ankylosing spondylitis
Crohn's disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
|
Celltrion
|
| Zarzio
|
filgrastim
|
Cancer
Haematopoietic stem cell transplant
Neutropenia
|
Sandoz
|
Data updated on 28 January 2022.
Source: ARCSA.
|
Five biomimics are also approved in Ecuador:
1. Epogen, Hemastin, Ior Epocim, erythropoietin biomimics, for the treatment of anaemia.
2. Etanar, etanercept biomimic, for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.
3. Reditux/Tidecron, a biomimic of rituximab, for the treatment of rheumatoid arthritis, non-Hodgkin's lymphoma and leukaemia.
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 [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 ‘biosimilars’ approved in Ecuador 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. Glosario de términos principales [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from: www.gabionline.net/es/biosimilares/general/glosario-de-terminos-principales
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