Colombia

Number of Biosimilars Available

Country Spotlight: Colombia

The National Institute of Food and Drug Monitoring (INVIMA – Instituto Nacional de Vigilancia de Medicamentos Y Alimentos) is responsible for inspecting and supervising the marketing and manufacturing of health products for use in Columbia, including the scientific evaluation of biologics and biosimilars. INVIMA comes under the Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia)

In Colombia, biosimilars are known as productos bioterapéuticos similares (similar biotherapeutic products).

Biosimilars Available

As of April 2016, there are 2 biosimilars approved for use in Columbia

A medicine used to treat Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis, and Ankylosing Spondylitis (entanercept)
A medicine used to treat Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis, and Ankylosing Spondylitis, Ulcerative colitis and Crohn’s disease (infliximab)[1]

Score Overview

Colombia is Partially Compliant.

The WHO guidance was compared to the relevant sections across the INVIMA guidelines resulting in an overall score for Colombia of 2.38/5. This means the INVIMA guidelines are partially or fully compliant with WHO in a few areas, but in more than half of the policy components, they are minimally or non-compliant with WHO standards.

The graph below shows individual scores by each of the 28 components of biosimilar policy

There are seventeen areas where INVIMA is not as specific as WHO, being either non-compliant or only partially compliant with WHO biosimilar policy.

Gaps

Gap 1

Scope:

When describing what is in scope, the guidelines do not mention that the biotherapeutic product should be well established and well characterized

Gap 2

Reference Product:

When comparing the biosimilar to the original medicine, the INVIMA guidelines do not specify that the same host cell should be used to produce the medicine.

Gap 3

Formulation:

This topic is not addressed by the INVIMA guidelines.

Gap 4

Route of Administration:

This topic is not addressed by the INVIMA guidelines.

Gap 5

Quality/analytical, General Considerations:

The guidelines do not address that an investigation into differences between the biosimilar and the original biologic should take into account lot-to-lot differences in commercial lots of the original biologic.

Gap 6

Quality/analytical, Isolation of Drug Substance:

This topic is not addressed by the INVIMA guidelines.

Gap 7

Quality/analytical, Physicochemical Analysis:

The guidelines do not specify that a comprehensive physiciochemical characterization should include a determination of the biologic’s primary and higher order structures (these structures show that the biologic has been put together correctly).

Gap 8

Quality/analytical, Biological Analysis:

The guidelines do not specify the intent of this analysis is to identify significant functional differences between the biologic and biosimilar

Gap 9

Quality/analytical, Immunological Analysis:

This topic is not addressed by the INVIMA guidelines.

Gap 10

Quality/analytical, Stability Studies:

This topic is not addressed by the INVIMA guidelines.

Gap 11

Nonclinical, Pharmacology (in vivo and in vitro)::

This topic is not addressed by the INVIMA guidelines.

Gap 12

Nonclinical, Toxicology:

This topic is not addressed by the INVIMA guidelines.

Gap 13

Clinical, Immunogenicity:

The guidelines do not mention the importance of post-marketing surveillance (the monitoring of a medicine in patients after it has been approved by regulatory authorities) for rare adverse events or antibody development with the biosimilar

Gap 14

Indication Extrapolation:

The guidelines do not provide the same degree of specificity as the WHO

Gap 15

Interchangeability:

This topic is not addressed by the INVIMA guidelines.

Gap 16

Naming:

This topic is not addressed by the INVIMA guidelines.

Gap 17

Labeling:

This topic is not addressed by the INVIMA guidelines.

Overall country score as compared to peers

History of Policy

Colombia released their final guideline for biologics, including biosimilars in September 2014.[2] The decree provides for three routes for biological products: a complete route, a comparability route and an abbreviated route which aims to facilitate the approval of biosimilars. The decree has been criticized by both the US and the European Union (EU)[3] who believe it will put patient safety at risk, and lacks an appropriate level of detail. In 2015, manufacturing and stability guidelines were released.

Policy Guidelines

Drug registration and monitoring biological and biotechnological origin

This guidance aims to establish standards and regulatory procedures to ensure the quality, safety, and efficacy of similar biotherapeutic products.
First issued September 2014; Most recent update September 2014

GMP guideline for biological drugs

This guideline defines the methods and procedures to ensure safe manufacturing of biologic medicines, including biosimilars.
First issued April 2015; Most recent update April 2015;

Side by side comparison of each of the score components

For each of the 28 components of biosimilar policy evaluated, the specific wording in the FDA's biosimilar policy is listed, alongside the accompanying wording in the WHO policy (shown in the blue box).

Scope

[§ 3.0] Well-established and well-characterized biotherapeutic products such as DNA-derived therapeutic proteins. A well-established biotherapeutic is one that has been marketed for a suitable period of time with proven quality, safety, and efficacy.

Excludes vaccines, plasma-derived products, and their recombinant analogues.

[Art. 1] All biological products, defined as products derived from living cells or organisms or their parts.

Excludes allergens, “magistral formulas” (product prepared in a pharmacy pursuant to a prescription) obtained from living organisms or from their tissue, and products containing or consisting exclusively of cells and/or non-viable human or animal tissue and which do not primarily exercise a pharmacological, immunological, or metabolic action.

[Art. 4] There are two pathways for the approval of follow-on biological products: (1) the “comparability route” (for the approval of products — biosimilars — on the basis of a comparability exercise); and (2) the “shortened route.”

[Art. 8] For the pharmacological evaluation of vaccines, the Pan American Network for Drug Regulatory Harmonization’s “Harmonized Requirements for the Registration of Vaccines” must be followed.

Concept of Biosimilarity

[§ 4] A biosimilar is a biotherapeutic product that is similar in terms of quality, safety, and efficacy to an already licensed RP.

Comparability route

[Art. 2] The comparability exercise involves a sequential and stepwise process of comparing the attributes of the biosimilar and Reference Product in terms of quality, safety, and efficacy.

[Art. 6] The comparability exercise must show that the biosimilar has a great degree of similarity in relation to the Reference Product. Differences must be explained and justified by the applicant.

When evaluating an application, the regulatory authority (INVIMA) will take into account the WHO’s “Recommendations for the evaluation of similar biotherapeutic products.”

Shortened route

[Art. 7] The concept of similarity is not addressed.

The product’s quality, safety, and efficacy should be sufficiently characterized by the use of state-of-the art analytical methods; the product should have a defined and highly documented safety and efficacy profile and substantial clinical experience; and solid PV information should be available.

This evidence must originate from one or more of the following authorities: (1) those listed in Art. 27 of Decree 677 of 1995; (2) the EMA; (3) the Organization for Economic Cooperation and Development (OECD) member countries and countries adhering to the OECD; and (4) authorities certified as “Reference” by the Pan-American Health Organization.

Comparability route and shortened route

[Art. 7] The product must be “a quality, safe, and effective” product.

[Art. 10] When evaluating an application, INVIMA will consider “global evidence” (the efficacy and safety profile, clinical trials, and PV information available worldwide of the product and/or other products containing the “same” active ingredient) and the product’s structural complexity.

Reference Product

[§ 7.0] The same RP should be used throughout the entire comparability exercise and it must be approved in the country/region in question (or, where the licensing country lacks an approved RP, approved and widely marketed in another jurisdiction with a well-established regulatory framework for, and experience in evaluation and post-market surveillance of, biotherapeutics).

[§ 8.1] As a general rule, the biosimilar product should be expressed and produced in the same host cell type as the RP. The applicant should determine the potential impact of changing the host cell on product quality, safety, and efficacy based on available evidence from public information and experience with previous use of the RP. The rationale for accepting a difference in host cell must be justified based upon sound science and clinical experience with the biosimilar or the RP.

Comparability route

[Art. 2] The reference product is a product that has been authorized by INVIMA or by another country through the submission of a full dossier.

[Art. 6] An reference product may be approved by an agency other than INVIMA if the other agency has an established regulatory framework with well-established principles and considerable experience in the evaluation of biological products and with PV processes. The authorities that meet these criteria are: (1) those listed in Art. 27 of Decree 677 of 1995; (2) the EMA; (3) the Organization for Economic Cooperation and Development (OECD) member countries and countries adhering to the OECD; and (4) authorities certified as “Reference” by the Pan-American Health Organization.

A product approved by one of these authorities may not serve as an reference product, however, if there are doubts about whether the product’s evaluation and approval meets Colombia’s standards.

Shortened route

Not addressed.

Formulation

[§ 8.1] The biosimilar manufacturer should assemble all available knowledge of the RP concerning the formulation used. The applicant should determine the potential impact of changing the formulation on product quality, safety, and efficacy based on available evidence from public information and experience with previous use of the RP. The rationale for accepting differences must be justified based upon sound science and clinical experience with the biosimilar or the RP.

Not addressed.

Dosage Form And Strength

[§ 5.0] Dosage form should be the same as that of the RP. Strength is not addressed.

[§ 8.1] The biosimilar manufacturer should assemble all available knowledge of the RP concerning the type of container closure system used. The applicant should determine the potential impact of changing the container closure on product quality, safety, and efficacy based on available evidence from public information and experience with previous use of the RP. The rationale for accepting a difference in container closure must be justified based upon sound science and clinical experience with the biosimilar or the RP.

Comparability route

[Arts. 3, 6] The applicant must submit the results of a comparability exercise between the biosimilar and the Reference Product accounting for the dosage.

Shortened route

[Art. 3] The applicant must submit information accounting for the dosage.

Comparability route and shortened route

The applicant must submit information evaluating the strength.

General Considerations

[§ 8] The application must contain a full quality dossier for both the drug substance and the drug product.

To evaluate comparability, the manufacturer should carry out a comprehensive physicochemical and biological characterization of the biosimilar in head-to-head comparisons with the RP. All aspects of product quality and heterogeneity should be assessed.

[§ 5] Development of the biosimilar involves a stepwise approach starting with characterization and evaluation of quality attributes. Differences should always be explained and justified and may require additional data.

[§ 8.2] Investigation of differences between the biosimilar and the RP should be based on knowledge of the relationship between quality attributes and clinical activity of the RP and related products, the clinical history of the RP, and lot-to-lot differences of commercial lots of the RP.

Comparability route

[Arts. 3, 6] The applicant must submit the results of a comparability exercise between the biosimilar and Reference Product accounting for the following attributes: (1) efficacy; (2) safety; (3) dosage; (4) indications, contraindications, interactions, and warnings; (5) benefit-risk ratio; (6) adverse effects; (7) immunogenicity; (8) PK; (9) marketing conditions; and (10) special restrictions. The extent to which information must be from clinical or nonclinical studies is not addressed.

Shortened route

[Art. 3] For the pharmacological evaluation, information must account for the following attributes: (1) efficacy; (2) safety; (3) dosage; (4) indications, contraindications, interactions, and warnings; (5) benefit-risk ratio; (6) adverse effects; (7) immunogenicity; (8) PK; (9) marketing conditions; and (10) special restrictions. The extent to which information must be from clinical or nonclinical studies, or must or may concern the product at issue or a comparator product, is not addressed.

Comparability route and shortened routes

[Art. 9] INVIMA may request additional information once, taking into consideration necessity/reasonableness in relation to experimentation with humans.

Physicochemical Analysis

[§ 8.2.1] The comparative physicochemical characterization should include the determination of primary and higher order structure and other biophysical properties using appropriate analytical methods (e.g. mass spectrometry, NMR).

The RP and the biosimilar are likely to contain a mixture of post-translationally modified forms, and appropriate efforts should be made to investigate, identify, and quantify these forms.

[Art. 8] For both the comparability and the shortened routes, the applicant must submit information about the product’s physicochemical properties.

Biological and Immunological Analysis

Biological

[§ 8.2.2] Comparative evaluation with a biological assay complements the physicochemical analyses by confirming the correct higher order structure of the molecule.

Ideally, the biological assay will reflect the understood MoA of the protein and will thus serve as a link to clinical activity.

The use of a relevant biological assay(s) with appropriate precision and accuracy provides an important means of confirming that a significant functional difference does not exist between the biosimilar and the RP.

Immunological

[§ 8.2.3] When immunochemical properties are part of the characterization (e.g., for antibody-based products), the manufacturer should confirm that the biosimilar is comparable to the RP in terms of specificity, affinity, binding kinetics, and Fc functional activity, where relevant.

Biological

[Art. 8] For both the comparability and the shortened routes, the applicant must submit information about the product’s biological identity and biological activity.

[Art. 12] The information submitted must include a description of the stages of collection, purification, characterization, quality control, stability, and biological activity of the active ingredient.

Immunological

Not addressed.

Impurities

[§ 8.2.4] It is recognized that the comparison of the impurity profiles between the biosimilar and the RP will be generally difficult. Nevertheless, process- and product-related impurities should be identified, quantified by state-of-the-art technology, and compared between the biosimilar and the RP. If significant differences are observed in the impurity profiles, their potential impact on efficacy and safety, including immunogenicity, should be evaluated.

[Art. 8] For both the comparability and the shortened routes, the applicant must submit information about the product’s purity evaluation.

[Art. 12] When appropriate, analytical certificates issued by the manufacturer and supplier should be included as part of the purity evaluation.

When dealing with fluids or tissues, the applicant must provide analytical reports with quality control results.

When components of human origin (cells, tissues, or fluids) are used as raw materials or manufacturing inputs, the applicant must certify compliance with Colombia’s Technical Standards on Hygiene and Health, or their equivalent issued by the country of origin’s authority.

Stability Studies

[§ 8.5] Head-to-head accelerated stability studies will be of value in determining the similarity of the products because they can reveal otherwise-hidden properties of a product that warrant additional evaluation. They are also important for identifying the degradation pathways of a protein product.

[Art. 25] The Department of Health and Social Protection must issue stability guidelines within three months of the issuance of final regulations.

Specifications

[§ 8.3] Specifications should capture and control important quality attributes known for the RP. Their setting should be based on the experience with the biosimilar and the results of the comparability evaluation, but should not be wider than the range of variability of the RP unless justified.

Specifications should be set as described in established guidelines and monographs, where these exist. Pharmacopoeial monographs may only provide a minimum set of requirements for a particular product, and additional test parameters may be necessary

[Art. 8] For both the comparability and the shortened routes, the applicant must provide the standards, technical specifications, and analytical methods for producing the necessary information for submission (if they are not included in the current and accepted pharmacopoeias in paragraph 1 of Article 22 of Decree 677 of 1995).

General

[§§ 9.1, 9.2] Nonclinical studies should use the final formulation intended for clinical use unless otherwise justified; the nonclinical evaluation encompasses a broad spectrum of PD, PK, and toxicity studies (per ICH S6); the amount of additional nonclinical data for safety and efficacy is dependent on product-specific factors (for example, quality, unknown or poorly understand MoA, significant toxicity, and/or narrow therapeutic index).

Comparability route

Shortened route

Pharmacology

[§ 9.2] In vitro studies: Assays like receptor-binding studies or cell-based assays should normally be conducted to establish comparability of PD activity.

In vivo studies: Animal studies should be designed to maximize information obtained; be conducted in relevant species (shown to possess PD and/or toxicological activity); and employ state-of-the-art technology. In vivo studies may not be needed if highly reliable in vitro assays that reflect clinically relevant PD activity of the RP are available.

Not addressed.

Pharmacokinetics

[§ 9.2] Nonclinical evaluation normally encompasses a broad spectrum of studies, including PK studies. The amount of data is highly dependent on the product and class-related factors.

Comparability route

[Arts. 3, 6] The applicant must submit the results of a comparability exercise between the biosimilar and the Reference Product accounting for PK. The extent to which the data should be from nonclinical or clinical studies is not addressed.

Shortened route

[Art. 3] The applicant must submit information accounting for PK. The extent to which information must be from clinical or nonclinical studies, or must or may concern the product at issue or a comparator product, is not addressed.

PK and PD

[§ 10] Clinical studies should be designed to demonstrate comparable safety and efficacy of the biosimilar to the RP and therefore need to employ strategies that are sensitive enough to detect relevant differences. The comparability exercise is a stepwise procedure that should begin with PK and PD studies followed by the pivotal clinical trials.

If any relevant differences between the biosimilar and the RP are detected, the reasons need to be explored and justified. If this is not possible, the new product may not qualify as a biosimilar and a full licensing application should be considered.

Comparability route

[Arts. 3, 6] The applicant must submit the results of a comparability exercise between the biosimilar and Reference Product accounting for PK. The extent to which the data should be from nonclinical or clinical studies is not addressed.

Shortened route

Efficacy Assessment

[§ 10.1] The PK profile should always be investigated. This is best achieved with single-dose, cross-over studies in a homogenous study population using a dose where the sensitivity to detect differences is largest. Where there are dose and time-dependent pharmacokinetics, it may be necessary to perform a comparative multi-dose study.

The traditional equivalence range is often used. If this range is not met, the biosimilar may still be considered similar with sufficient evidence from other comparisons.

[§ 10.2] PD studies may be advisable prior to efficacy and safety trials if differences of unknown relevance have been detected in PK studies. In many cases, PD parameters are investigated in the context of combined PK/PD studies.

Comparability route

[Arts. 3, 6] The applicant must submit the results of a comparability exercise between the biosimilar and Reference Product accounting for efficacy. The extent to which information must be from clinical or nonclinical studies is not addressed.

Shortened route

[Art. 3] For the pharmacological evaluation, information must account for efficacy. The extent to which information must be from clinical or nonclinical studies, or must or may concern the product at issue or a comparator product, is not addressed.

Safety

[§ 10.3] Usually, clinical trials are required to demonstrate similar efficacy. Confirmatory PK/PD may be used in lieu of efficacy trials provided there is sufficient knowledge of the PK/PD profile of the RP, at least one PD marker has a well-established relationship to efficacy, and the relationship between dose/exposure, the relevant PD marker, and response/efficacy of the RP is established.

[§ 10.4] Similar efficacy means similar treatment effects are achieved at the same dosages.

Similar efficacy will usually have to be shown in a controlled, adequately powered, study that is, preferably, double blind. Potential differences between the products should be investigated in a sensitive and well-established clinical model.

Comparability route

[Arts. 3, 6] The applicant must submit the results of a comparability exercise between the biosimilar and Reference Product accounting for safety, contraindications, interactions, warnings, benefit-risk ratio, and adverse effects. The extent to which information must be from clinical or nonclinical studies is not addressed.

Shortened route

[Art. 3] For the pharmacological evaluation, information must account for safety, contraindications, interactions, warnings, benefit-risk ratio, and adverse effects. The extent to which information must be from clinical or nonclinical studies, or must or may concern the product at issue or a comparator product, is not addressed.

Immunogenicity

[§ 10.5] Safety data should be obtained in a sufficient number of patients to provide a comparison of type, frequency, and severity of adverse events. Safety data from the efficacy trials may be sufficient for this purpose (or may need to be extended), but in any case additional monitoring is usually necessary after approval.

Comparability route

[Arts. 3, 6] The applicant must submit the results of a comparability exercise between the biosimilar and Reference Product accounting for immunogenicity.

Shortened route

[Art. 3] For the pharmacological evaluation, information must account for immunogenicity.

Comparability route and shortened route

[Art. 8] The applicant must submit test results for the product, including clinical tests, to determine immunogenic effects.

[Art. 25] Within three months of the issuance of these regulations, the Ministry of Health and Social Protection must issue immunogenicity guidelines regarding principles, methods, and techniques enabling the discovery of potential immune toxic reactions and the potential appearance of neutralizing antibodies.

Extrapolation of Indications

[§ 10.6] Immunogenicity should always be investigated in humans prior to authorization, because animal data are usually not predictive and because it could affect PK, PD, or safety. Generally, the data from a comparative efficacy trial will be sufficient prior to market authorization, subject to appropriate post-market pharmacovigilance for rare adverse events or where clinically meaningful or serious antibody development has been encountered in the RP or substance class.

In the case of chronic administration, one year of data prior to market authorization is usually appropriate.

[§ 10.6] Antibody assays need to be validated for their purpose. Detected antibodies need to be characterized for their clinical implications with special attention to the possibility of interaction with endogenous protein.

[Art. 11] For both the comparability route and the shortened route, the approval of indications must be supported by evidence of their safety and efficacy. A product’s approved indications will be those claimed and proven by the applicant and/or the indications listed in pharmacological standards for the product’s active ingredient.

Risk Management Plans

[§ 10.7] Extrapolation to other approved indications of the RP may be possible if all of the following conditions are met: (1) a sensitive clinical test model has been used that is able to detect potential differences between the products; (2) the clinically relevant MoA and/or receptors are the same (or, if the MoA is different or not known, a strong scientific rationale and additional data will be needed); (3) safety and immunogenicity of the biosimilar have been characterized and there are no special safety issues expected with the extrapolated indication; and (4) if the efficacy trial used a non-inferiority study design and demonstrated acceptable safety and efficacy of the biosimilar compared to the RP, the applicant should provide convincing arguments that this finding can be applied to the extrapolated indications.

If these prerequisites for extrapolation of efficacy and safety data of the biosimilar to other indication(s) of the RP are not fulfilled, the manufacturer will need to submit its own clinical data to support the desired indication(s).

[Art. 25] The Department of Health and Social Protection must, within six months of issuance of the regulations, issue guidelines concerning the preparation of RMPs that take into consideration different types of biologics.

[Art. 31] The licensee must implement an RMP and an active PV program. The licensee must submit periodic safety reports and follow-up reports on product use and comply with the Good Pharmacoviligance Practices adopted by the Department of Health and Social Protection.

The licensee must follow INVIMA’s guidelines concerning the use of traceability technology.

Interchangeability

[§ 11] Data from pre-authorization clinical studies are usually too limited to identify all potential unwanted effects of a biosimilar, and in particular, rare adverse events.

Therefore, further close monitoring of the clinical safety of these products in all approved indications and continued benefit-risk assessment is necessary in the post-market phase.

A safety specification and PV plan are required at the time of submission, describing safety issues for the RP, the class, and/or the biosimilar.

Any special safety monitoring imposed on the RP or product class should be incorporated into the PV plan for the biosimilar, unless there is a compelling justification not to do so.

The regional authority should provide a framework establishing the ability to ensure specific identification of the biosimilar (i.e., traceability). There should be a legal framework adequate to identify any biotherapeutic marketed in its territory that is the subject of adverse event reports.

Not addressed.

Naming

Not addressed specifically. To be determined by national authorities.

[§ 6, bullet e] Biosimilars “are not generic medicines; and many characteristics associated with [that] authorization process generally do not apply.”

[§ 12] The biosimilar should be clearly identifiable by a unique brand name, and the prescribing information should be as similar as possible to that of the RP except for product-specific aspects such as different excipients.

Note: Naming and interchangeability should be treated as separate issues. WHO has recommended a generic name plus numbering system. Naming, per se, is not about the basic science of interchangeability.

Not addressed.

Labeling

[§ 12.0] A biosimilar should be clearly identifiable by a unique brand name. Where an international non-proprietary name (INN) is defined, it should be stated. The WHO’s policy on INNs should be followed. The provision of a lot number is essential and critical for traceability.

[Note: In July 2014, the WHO issued a proposal for unique biologic identifiers (BQs) that could be added to the INNs of biologics, whether innovative or biosimilar. See INN Working Doc. 14.342 (July 2014).]

Not addressed.

Considerations for Quality by Design

[§ 12] The prescribing information for the biosimilar should be as similar as possible to that of the RP, except for product-specific aspects, such as different excipient(s). This is particularly important for posology and safety-related information, including contraindications, warnings, and adverse events.

If the biosimilar has fewer indications than the RP, the related text in various sections may be omitted unless it is considered important to inform doctors and patients about certain risks (e.g. because of potential off-label use). In such cases it should be clearly stated in the prescribing information that the biosimilar is not indicated for use in the specific indication(s) and the reasons why.

The national regulatory authority may choose to mention the biosimilar nature of the product and the studies that have been performed with the biosimilar, including the specific RP, in the product information.

The national regulatory authority may choose to include instructions for the prescribing physician on how to use biosimilar products.

[Art. 7] The shortened route may be appropriate if, among other things, the product’s active ingredient is sufficiently characterized by the use of state-of-the-art analytical methods.

[Art. 12] The protocols and specific characteristics for the donation, selection, collection, and description of cells, tissues, or fluids must be “itemized” to ensure quality and reduce risk.

[Art. 13] The WHO’s recommendations on good manufacturing practices generally apply. The applicant must submit certificates of compliance with Good Manufacturing Practices “for the manufacturing plant of the active pharmaceutical ingredient, the bulk product (if applicable), the packer and the finished product.”

Footnotes

[1] Source: http://gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia

[2] Sources: http://www.gabionline.net/Guidelines/Colombia-issues-draft-decree-for-registration-of-biologicals

[3] https://www.bio.org/advocacy/letters/bio-wto-comments-colombia%E2%80%99s-proposed-biologics-and-biosimilars-regulations

CBPE

Number of Biosimilars Available

Country Spotlight: Colombia

Biosimilars Available

Score Overview

Colombia is Partially Compliant.

Scores by measured component

Gaps

Gap 1

Gap 2

Gap 3

Gap 4

Gap 5

Gap 6

Gap 7

Gap 8

Gap 9

Gap 10

Gap 11

Gap 12

Gap 13

Gap 14

Gap 15

Gap 16

Gap 17

Overall country score as compared to peers

History of Policy

Policy Guidelines

Side by side comparison of each of the score components

Footnotes