Biosimilars & Biologics
The key facts about biosimilars and biologics in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99.
1. Are biosimilar medicines considered the same as generic medicines in your country?
No, generic medicines are understood as medicines with the same structure of the active substance as the reference medicine. And biosimilar medicines are those biotech molecules that can have a few structural differences with the biotech molecule of the reference product (due to complexity of biotech products) and, also the biosimilar medicine must show high similarity in quality, safety, and efficacy attributes in comparison with the reference medicine through a comparability assessment.
2. Are all biologic medicines, including biosimilar medicines, patentable in your country?
No, in Colombia biosimilar medicines cannot be patentable. However, biologic medicines include also biotech medicines and, these products are patentable in Colombia if are the innovator products.
3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?
Yes, all the biologic and biotech medicines, including also biosimilar medicines are regulated under Decree 1782 of 2014 which is the main core of the regulatory framework. This regulatory framework is composed of Resolutions: 5402 of 2015, 3690 of 2016, 4490 of 2016, 553 of 2017, and 2950 of 2019. Although are some requirements and articles of Decree 677 of 1995 that apply also for biologic including biotech and biosimilar drugs.
4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?
The requirements regarding the data package to obtain approval for a biosimilar drug are the same requirements for the original/innovator/reference biologic drug. These requirements are contained in Articles 72, 73, 74, and 76 of Decree 677 of 1995.
5. What are the requirements for the choice of the reference comparator product?
These requirements are detailed in point 4 of the technical annex of the Resolution 2950 of 2019. In summary, the reference product chose must be appropriate to support the marketing authorization application and will be used through all the comparability assessments, the manufacturer of the biosimilar product must demonstrate the similarity between the active substance of the biosimilar and the reference product, the pharmaceutical form of both products must be the same. If the reference product has been approved in Colombia its approval concept has to be done under the full file pathway but, if the product has not been approved in Colombia yet, the reference product must be authorized and widely marketing in reference countries.
6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?
Please refer to point 5. The reference product must be authorized and widely marketing in reference countries that have a regulatory framework with well-established principles and considerable experience in biological drug evaluation and pharmacovigilance activities, the information of the reference product must be available for INVIMA´s assessment, and is important to notice that the acceptance of the reference product for the assessment of a biosimilar product does not imply the approval concept for the biosimilar product by INVIMA to the use of that product in Colombia.
7. How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?
The prices of medicines are regulated under the methodology developed for the direct price control regime for the drugs that are marketed in the national territory, this methodology is supported on Circular 03 of 2013. Currently, the Ministry of Health published what will be the Circular 012 of 2021 with which the list of medicines subject to the direct price control regime is unified and added, and their Maximum Sale Price is set, in addition to issuing new guidelines related to the regulation of prices of Vital Drugs Not Available.
8. What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?
The reimbursement regulatory framework for biologic, biotechnological (reference products and biosimilar) medicines are Resolutions 205 and 2152 of 2020.
9. Does biosimilar competition impact the reimbursement policy of the originator reference products?
No, the biosimilar competition does not impact the reimbursement policy of the reference products. It only leads to increased competition in the market.
10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?
The regulatory framework for drug prescribing and dispensing is composed of the Decree 780 of 2016.
11. Is the system considering physician-led switching and/ or pharmacy-level substitution (without involvement of the clinical decision maker)?
No, this switching is not considering by the system.
12. What are the post-authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?
Are periodic reports of security used to monitor the use of the medicines, using information from different notification sources, as established in current regulations, and comply with the Good Pharmacovigilance Practices desired by the Ministry of Health and Social Protection. And is not any difference between requirements for original biologic drugs and biosimilar drugs.
13. Are there specific policies and requirements for labelling biosimilar medicines in the event of second medical use patents? Is this any different from the requirements for the original Biologic drug?
In Colombia, for all medicines the second medical uses are not recognized as new entities, this means that is not possible to find second medical use patents on the market.
14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)
Yes, are two Decrees: 697 of 2021 ¨By which the health requirements that will be taken into account in the donation of chemical synthesis, biologics, radiopharmaceuticals, phytotherapeutic products, medicinal gases, homeopathic medicines, medical devices, biomedical equipment, in vitro diagnostic reagents, cosmetics, and household hygiene products and personal hygiene absorbents, and raw materials, to attend the COVID-19 pandemic¨. And Decree 710 of 2021 ¨Whereby articles 9 and 10 of Decree 1787 of 2020 are modified, regarding the issuance, validity, information, renewals, and modifications of the Sanitary Authorization for Emergency Use ASUE¨. Both Decrees impact biosimilars regulatory framework.
15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?