Biosimilars & Biologics
All legal aspects surrounding biosimilars & biologics in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99.
1. Are biosimilar medicines considered the same as generic medicines in your country?
No, biosimilar medicines have their own legal regime. ANMAT does not use any specific term such as “biosimilar” or “biocomparable”, but defines this type of biological medicines as: “medicinal specialties of biological origin whose proposed quali-quantitative composition, therapeutic indications and route of administration, originate in other medicinal specialties of biological origin authorized and registered with the national health authority or other regulatory health authority (reference biological medicine), about which there is evidence of its commercialization and sufficient characterization of its risk-benefit profile”.
2. Are all biologic medicines, including biosimilar medicines patentable in your country?
New molecules and new processes for preparing them are deemed patentable as a general principle. There are no specific rules or case law in connection with the patentability of biosimilars. In any case, it should be borne in mind that several inventions related to biological medicines or biosimilars are excluded from patentability. Methods of treatment, for instance, are excluded from patentability under the Argentine Patent Law. Also, the Patent Office’s Patentability Guidelines severely restrict the patentability of inventions in the pharma field such as compositions and formulations, dosage regimes, selection inventions and second medical uses.
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. The registration application for biosimilars is regulated by ANMAT Regulation No. 7,729/2011 and complemented by ANMAT Regulation No. 7,075/2011. The biosimilar products obtained through recombinant DNA are regulated by ANMAT Regulation No. 3,397/2012.
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?
Biological and biotechnological products have a different registration and authorization procedure from the one applicable to biosimilar products. The registration of original biological or biotechnological products requires the filing of a full-dossier whereas the registration of a biosimilar product requires the filing of an abbreviated dossier. Only those biological products containing well characterized proteins may qualify for registration.
The comparability test should show that the biosimilar product is similar to the reference product in terms of quality. Therefore, appropriate physical-chemical and biological trials that allow a detailed characterization of the product should be carried out.
Also, preclinical and clinical studies should be performed on the biosimilar product. Their complexity and scope will be determined on a case-by-case basis and will depend on:
- The nature of the active substance and its structural complexity (structure/function relationship);
- Information of “in vivo” performance of the active pharmaceutical ingredient and/or product;
- Impurities (profiles of compared impurities);
- Information on the post-marketing performance of similar products, understanding the importance of clinical experience with similar active pharmaceutical ingredients and/or similar products; and
- The relationship between known adverse effects and molecular characteristics.
5. What are the requirements for the choice of the reference comparator product?
The reference product must be authorized by ANMAT and commercialized in Argentina. Alternatively, a foreign authorization may also be considered if registered by a country with high sanitary surveillance. Please see Question 6 below for more information.
6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?
A medicinal specialty of biological origin authorized in a foreign country by the relevant health authority may be considered a reference product if the applicant proves that there is enough experience and knowledge regarding its use and commercialization in the market, and information and/or documentation about its characteristics and specifications. In this sense, the reference product must be authorized and broadly commercialized in the foreign country or group of countries as long as their regulatory institutions and framework are in accordance with those of Argentina. The comparability process will be accompanied by preclinical and clinical studies whose extension will depend on the results obtained during said process.
7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?
To date, ANMAT has not issued specific regulations for fixing prices applicable to the products under its control (including biologic and biosimilar products).
8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?
Yes, it might because private and public healthcare insurance providers will try to obtain reimbursement of the biosimilar product when is less expensive than the original product.
If a biologic drug and/or a biosimilar are included in the Mandatory Medical Plan (PMO, after its acronym in Spanish), the reimbursement is guaranteed. If that is not the case, the regulations protect the access to treatments considered to be of high cost, but the extension of the coverage may vary.
The reimbursement policy for biosimilars, in practice, might be different because of a joint regulation of the MoH and that Secretary of Trade that gives preference to those nationally manufactured products that are available in the market with the same active ingredient or biosimilar as those manufactured abroad, provided that their final sale price is significantly lower than the average price of the similar/biosimilar foreign manufactured medicines.
9. Does biosimilar competition impact the reimbursement policy of the originator reference products?
There is no difference between the prescribing and dispensing of biosimilars and the requirements for the original biologic drugs.
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?
In principle, biological/biosimilar products are considered to be interchangeable.
The Law on Generic Pharmaceutical Products No. 25,649 was issued with the aim of guaranteeing the patients’ right to acquire a prescription drug under its generic name and without being obliged to purchase a specific brand. Therefore, patients can request the pharmacist to provide information of all medical specialties containing the same active pharmaceutical ingredient or a combination of them, the same dosage, same pharmaceutical form and similar units. Pharmacist will be obliged to substitute the prescribed medicine with the same active ingredient, if requested by the patient.
11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?
Specific rules for switching a biologic medicine for a biosimilar is a pending matter to be properly addressed and regulated in Argentina. Interchangeability is up to the treating physician’s medical criterion and patient’s will, in accordance with a reasonable and comprehensive interpretation of local legal framework. Several health care professionals’ associations have expressed their rejection to a physician-led switching without the consent of the patient and to a pharmacy-level automatic substitution.
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?
The holder of the marketing authorization of biological or biosimilar products must have an appropriate system for post-marketing pharmacovigilance. A trained professional must be appointed to be in charge of supervision, and adequate measures for the notification of all adverse events that occur in Argentina and in other countries where the same product could be in commercialization.
On the other hand, the marketing authorization holder of a biological and/or biosimilar product will have to file a risk management plan in addition to the post-marketing pharmacovigilance system.
13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?
Second medical uses are excluded from patentability under the Patent Office’s patentability guidelines.
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)
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?
There are no proposals of reforms to the legal framework of biologic drugs or biosimilars. Nevertheless, the situation could change considering the health emergency declaration (December 23, 2019), established by Law No. 27,541, that strengthens the Ministry of Health’s regulatory powers until December 31, 2021.