In Peru, the regulatory body responsible for approving biological drugs is the General Directorate of Medicines, Supplies and Drugs (DIGEMID) of the Peruvian Ministry of Health (MINSA) which is in charge of leading the National and Decentralised Health System, the policy for the universal health assurance and the policies and intersectoral actions on social determinants [1].
DIGEMID is the line organisation of MINSA, under the Vice Ministry of Public Health, which constitutes the the National Authority of Pharmaceutical Products, Medical Devices and Health Products referred to under Law No. 29459, Law of Pharmaceutical Products, Medical Devices and Health Products. It is the technical standard authority at national and sectorial level, responsible for proposing regulations and standards within its scope, as well as evaluating, executing, controlling, supervising, monitoring, auditing, certifying and accrediting in matters related to the provisions of Law N° 29459.
It has four organizational units: 1) Directorate of Pharmaceutical Products; 2) Directorate of Medical Devices and Health Products; 3) Directorate of Inspection and Certification; and 4) Directorate of Pharmacovigilance, Access and Use.
In 2016, DIGEMID finalized the guidelines for biological products opting for the similarity route.
MINSA defines a biosimilar drug as a biological product, which in terms of quality, safety and efficacy, is similar to a reference biological product (RBP).
The first biosimilar to receive approval in Peru was Celltrion’s monoclonal antibody Flixceli (infliximab) in 2016.
To date, MINSA has approved two biosimilar monoclonal antibodies [2] for use in Peru, see Table 1.
| Tabla 1: Biosimilars approved by MINSA
|
| Product name
|
Active substance
|
Therapeutic area
|
Authorization date
|
Manufacturer/ Company name
|
| Clotinab
|
abciximab
|
Anticoagulant
|
Not available
|
ISU Abxix Co, Ltd
|
| Flixeli
|
infliximab
|
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Crohn's disease
Ankylosing spondylitis psoriasis
|
2016
|
Celltrion/Lab AC FARMA
|
Data updated on 1 October 2021.
Source: DIGEMID, MINSA
|
Two biomimics of rituximab are also authorized in Peru:
1. Kikuzubam for the treatment of non-Hodgkin's lymphoma
2. Reditux/Tidecron 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 [3].
Editor's comments
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 Peru 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. 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 2021 Oct 1]. Available from: www.gabionline.net/guidelines/peru-issues-decree-for-the-registration-of-medicines-and-biological-products
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. Glosario de términos principales [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 1]. Available from: www.gabionline.net/biosimilars/general/glosario-de-terminos-principales
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