Legal & Regulatory > Ecuador > Biosimilars and Biologics

Biosimilars and biologics in Ecuadorian pharma – a comprehensive legal overview. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

1. Are biosimilar medicines considered the same as generic medicines in your country?

No, the generic term is used only for chemical synthesis medicines and the term biosimilar is used for medicines of biological origin.

The biosimilar medicine is similar in terms of quality, safety and efficacy to the reference biological medicine. It is necessary for a biosimilar medicine to demonstrate through its comparability exercise its equivalent capacity to the reference biological medicine.

2. Are all biologic medicines, including biosimilar medicines, patentable in your country?

All medicines are patentable, regardless of its nature, provided it meets the patentability requirements requested by current Laws (Andean Decision No.486 and local IP law)

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, in order to obtain the marketing authorization of a biosimilar, it is necessary to comply with Ministerial Agreement 385 “Reform and Codification of the Regulations for obtaining marketing authorizations, control and surveillance of biologicals for human use”

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 information necessary to obtain a marketing authorization of a biosimilar is similar to that of a biological one, with the difference that non-clinical studies are not necessary and clinical studies should be submitted as appropriate and must comply with the following:

• Administrative information and prescription information.
• Summaries of common technical documents.
• Quality information.
• Studies of physicochemical and biological characterization of the active pharmaceutical ingredient and the finished product.
• Pharmacovigilance program (risk management plan).
• Studies of non-clinical comparability of the biosimilar medicine compared to the reference biological medicine and should include at least:
  • Toxicity
  • Pharmacokinetic and pharmacodynamic studies in at least one suitable model in animals.
  • Local tolerance test.
  • Immunogenicity studies and reports of these studies according to the ICH guidelines.

The scope and magnitude of clinical studies will depend on the size of the residual uncertainty about the biosimilarity of the two products after performing a structural and functional characterization.

5. What are the requirements for the choice of the reference comparator product?

When choosing a reference biological medicine in a comparability study, the following considerations should be taken into account:

• The reference biological medicine must have been marketed for at least one year, so that the demonstration of similarity with this product highlights a substantial amount of acceptable data regarding its safety and efficacy.
• The manufacturer shall demonstrate that it is appropriate to support the application for authorization to market the biosimilar medicinal product.
• Must have been registered on the basis of complete quality, safety and efficacy data.
• Use the same reference biological medicine throughout the entire biosimilar medicine development process.

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

Yes, the reference biological medicine must be authorized and marketed by at least one of the countries whose drug regulatory agencies have been qualified by the Pan American Health Organization (PAHO), as Regional Reference Authorities, or hold a marketing authorization granted by Health Authorities of:

• Usa
• Canada
• Australia
• South Korea
• UK
• European Medicines Agency (EMA) process

7. How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?

The price regulation system is the same as that of a biological medicine, once the marketing authorization of the biosimilar medicine has been approved, the proceeding must be confirmed in the Technical Secretariat for the Approval of Prices for Drugs, who will determine if the price is regulated or free.

8. What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?

The return or refund policy does not exist in biosimilar medicines in Ecuador.

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

n/a

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 Health Law establishes that health professionals are the only ones authorized to prescribe prescription medications, regardless of their nature, whether they are chemical synthesis or biological. In public institutions the prescription will be mandatory according to the legally established protocols and treatment schemes.

The dispensing of biosimilar medicines will depend on the corresponding health risk, and may be found in establishments approved by the National Authority for the sale of these products (pharmacies).

11. Is the system considering physician-led switching and/ or pharmacy-level substitution (without involvement of the clinical decision maker)?

No, the prescription of medications can only be given by a health professional, and will be said professional who determines the use of the medication in relation to the therapeutic information, as well as the scientific evidence of the product.

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?

No, they are the same as for biological medicines and the subsequent requirements once the health record is obtained are:

• Price approval.
• Post-registration control (sampling).
• Records of adverse reactions and submission of periodic updated safety reports (PSUR)

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?

No, they must comply with the labeling requirements of biological medicines and must include:

• Secondary container:
  • Name of the medicine
  • International Nonproprietary Name, when applicable or name of the active substance when there is no INN
  • Type of biological medicine (vaccine, blood products, processed and related products, biotechnology, biosimilar and other biological medicines)
  • Concentration, potency or viral titer, as appropriate
  • Dose
  • Number of doses per vial (for multidose presentation), as appropriate
  • Route of administration
  • Lot number
  • Qualitative quantitative formula in biological units with their equivalence in units of weight. Including excipients. It should be added where appropriate the INN of ingredients.
  • Pharmaceutical Form of the product
  • Package contents using the international system
  • Temperature and storage conditions
  • Solutions used to dilute where appropriate
  • Preparation instructions and use instructions
  • Name of the manufacturer, city and country of this laboratory
  • In the case of products packaged by a third party other than the manufacturer, the name of each party must be declared, indicating their participation status
  • Manufacturing and expiration date – health registration number o Modality of sale o General warning: “Delicate product. Administer by prescription and medical surveillance ”
  • Additional warnings in accordance with the active substance (s) of the product
  • If the product has been teratogenic, for any of the animal species contemplated in toxicological preclinical studies, the warning: “Contraindicated in pregnancy or when its existence is suspected”

• Primary container (label)
  • Name of the medication
  • INN when applicable or name of the active ingredient when there is no INN
  • Content expressed in the international system
  • Dose
  • Number of doses per vial (for multidose presentation), as appropriate
  • Qualitative quantitative formula in biological units with their equivalence. Excipients can be excluded when the package is very small.
  • Route of administration
  • Manufacturer’s name
  • Lot number or code
  • Temperature and storage conditions
  • Manufacturing and expiration dates
  • If the product has been teratogenic, for any of the animal species contemplated in toxicological preclinical studies, the warning: “Contraindicated in pregnancy or when it existence is suspected”

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)

The only change has been that Ministerial Agreement No. 3344 “Regulations for obtaining marketing authorizations, control and surveillance of biologicals for human use” was repealed and replaced by Ministerial Agreement No. 385 “Reform and codification of the Regulations for obtaining marketing authorizations, control and surveillance of biologicals for human use”.

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?

No.