Biological drugs have been a breakthrough in the treatment of many diseases, but their cost is usually high, so the development and approval of similar biotherapeutic products has greatly facilitated access for patients, especially in developing countries. That is why Colombia issued guidelines including all these similar biotherapeutic products .
More recently, the Ministry of Health and Social Protection of Colombia published resolution 2950 of 2019, which issues the current Guía para la Evaluación de la Comparabilidad de Medicamentos Biológicos (Guide for the Comparability Assessment of Biological Drugs).
This guide is created under the premise that comparability studies are the cornerstone of the development of similar biotherapeutic products. Its development depends to a large extent on comparability studies carried out in order to establish biosimilarity with the reference biological drug (RBD).
The main objective of creating this guide was to establish the requirements and procedures that must be taken into account by those who want to obtain the health registration of biological drugs in Colombia. It provides the guidelines for the completion and evaluation of the comparability exercise, complete or in some of its phases, in the process of obtaining the health registration of a competing biological drug (CBD) through the comparability route, or when there are relevant changes in the manufacturing process in a biological medicine with a health registration that may affect the quality, safety and efficacy of the product, regardless of whether the drug is a pioneer or competitor.
Reference Biological Drug (RBD)
Since choosing an RBD is essential for the evaluation of a CBD, the considerations to be taken into account for its selection are presented in Table 1.
| Table 1: Considerations in choosing a reference biological drug in Colombia
| If the RBD has a health registration
|| If the RBD does not yet have a health registration
| - The manufacturer must demonstrate that the chosen RBD is appropriate to support the application for the marketing authorization of the CBD
|| - It must be widely authorized and marketed in reference countries with a well-established regulatory framework and principles and considerable experience in the evaluation of biological medicinal products and pharmacovigilance activities
| - The same RBD should be used in the development of the entire comparability exercise, i.e. in the quality comparison and in non-clinical and clinical studies
|| - The information in the RBD assessment and approval dossier must be accessible to INVIMA, i.e. information registered with other agencies and/or publicly accessible to INVIMA evaluators
| - The similarity between the active pharmaceutical ingredient of the RBD and CBD must be demonstrated
|| - Acceptance of an RBD for the evaluation of a CBD in one country does not imply its approval by INVIMA for use in Colombia
| - The pharmaceutical form, dose, and route of administration of the CBD should be the same as the RBD
|| -The Specialized Chamber of the Review Commission in a justified manner may reject the use of an RBD approved by one of the reference authorities, when the specific evaluation process of the reference drug does not account for or raises doubts about the attributes referred to in article 4 of Decree 1782 of 2014
| - A CBD that has been approved through the comparability pathway should not be used as an RBD, as it was authorized using a reduced non-clinical and clinical data package.
This guide is based on the principle that high similarity in the quality, physicochemical, and functional level of the CBD in relation to the RBD is a prerequisite in all cases.
The decision regarding the health registration must be based on the totality of the evidence, which includes quality, non-clinical, and clinical parameters information of the RBD and the CBD.
This guide can be consulted at the following link:
Guide for Assessing the Comparability of Biological Drugs
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 ‘similar biotherapeutic products’ approved in Colombia might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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1. GaBI Online – Colombian guidelines for productos bioterapéuticos similares [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 17]. Available from: www.gabionline.net/guidelines/Colombian-guidelines-for-productos-bioterapeuticos-similares
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