The Mexican Academy of Dermatology (AMD) is a non-profit civil association founded in 1952 and formed by a group of relevant dermatologists dedicated to sharing experiences and keeping up to date with the latest advances in research. This group has developed the following position statement on biosimilars for psoriasis.
It is worth mentioning that the expiration of patents on some innovative biological agents has led to the development of biocomparables. Specifically, expired patents on biological therapies with proven efficacy in psoriasis have led to the production of new, more cost-effective biotechnological drugs. This has resulted in considerable savings for both health systems and patients, facilitating their access to these drugs.
Currently, biocomparables of infliximab, etanercept and adalimumab exist or are under development in Mexico for the treatment of psoriasis.
In the field of dermatology, the American Academy of Dermatology was the first academic group to establish its general position regarding the use of biosimilars. But in the particular use of biosimilars for psoriasis, it was the Spanish Academy of Dermatology and Venerology who was the first publishing a position statement on the use of biosimilars in psoriasis in 2015 [1], followed by other position statements by patient groups and psoriasis-focused foundations.
The AMD based its position paper on the analysis of the systematic review of the literature. The document consists of 14 questions with dichotomous answers that were presented to the members of the AMD, together with the results and discussion of the systematic review, and were answered by a total of 133 faculty members. Based on their responses, the final position statement paper was then produced, which states the following [2]:
1. An innovative biotechnological drug is one that has been developed and registered in the world for the first time for one or more indications.
2. A biocomparable is a biological product/medicine which, by means of molecular biology techniques, is intended to achieve a structure and function comparable to those of the innovative biological product.
3. Obtaining biotechnological products requires a complex process that does not guarantee that biocomparable medicines are equal to innovative biotechnological drugs and, therefore, due to the lack of scientific evidence on their efficacy, safety and interchangeability, biocomparable medicines should not be considered as interchangeable.
4. In psoriasis, there is limited evidence of the safety and efficacy of the interchangeability of a reference biological drug to a biocomparable medicine, so it would not be correct to accept the practice of drug substitution.
5. The approval of a biocomparable must meet the preclinical and clinical studies indicated by Mexican law (Internal Regulations of the New Molecules Committee).
6. Each product must clearly detail in its nomenclature that it is an innovative biotechnological drug or a biocomparable since this is crucial for its correct pharmacovigilance.
7. The manufacturer of any biotechnological drug is obliged to carry out long-term pharmacovigilance activities and all secondary effects must be reported to COFEPRIS portal (https://www.gob.mx/cofepris).
8. It is highly recommended that health professionals report, without exception, any adverse reaction that could be produced by the use of biotechnological drugs.
9. The appropriate use of biotechnological drugs is the responsibility of the joint work of physicians, pharmacologists and regulatory health entities.
10. A stable patient with the reference product should not be switched to a biocomparable medicine only for economic reasons.
11. In new patients for biological treatment, the therapeutic decision between approved biologicals (reference or biocomparable) should be dictated by an individual risk/benefit assessment and not be based exclusively on economic aspects.
12. In the absence of safety and efficacy data for the biocomparable, extrapolation of indications should not be performed or accepted based merely on the approval obtained by the reference product in COFEPRIS, since each disease behaves differently and therefore the clinical results may be different even in the case of a biocomparable molecule.
13. We state that this working group is in favour of the development of biocomparable biotechnological drugs, both in Mexico and in other parts of the world, as well as their approval without external interference by regulatory agencies as long as:
- in addition to demonstrating their pharmacokinetic equivalence, they are subjected to the highest quality standards in terms of production and development
- they undergo a comparison of their efficacy and safety against the reference product by means of Phase III and IV studies with adequate statistical power
- and that they are followed by a strict pharmacovigilance program.
14. The goal for the development of biocomparables should include: a) substantial savings for public health institutions; b) patients should be able to acquire these drugs on an out-of-pocket basis; c) access to these drugs should be favoured by broader sectors of the population; and d) the economic factor should not take precedence over therapeutic efficacy and optimal patient safety.
In conclusion, the AMD members expressed their support for the development of biocomparable biotechnological drugs, as long as they meet the highest quality standards. In addition, other factors such as the efficacy and safety of these drugs should also be taken into consideration in the decision to prescribe a biosimilar, the main purpose of which is to save money for patients and health systems.
In 2015, a position statement on the approval of biosimilars in Latin America was made during the Fifth Latin American Biosimilars Forum (FLAB) held in Brasilia, Brazil, with the theme 'Interchangeability and automatic substitution'. Babini et al. published a FLAB position statement on the approval of these monoclonal antibody biosimilars in the context of current regulations in Brazil and Argentina [3, 4].
Conflict of Interest
The cost of developing this consensus was covered by AbbVie Laboratories, this company did not intervene in the generation of the draft nor did it direct the content of the statements.
For full details on the authors' conflict of interest, see the research paper [1].
Editor’s comment
Readers interested to learn more about use of biologicals in dermatology are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Use of biologicals in dermatology – following the agreed path or going off-piste? A brief report
GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.
Readers interested in contributing a research or perspective paper in Spanish and/or English on biosimilar medicines in gastroenterology to GaBI Journal – an independent, peer reviewed academic journal – please submit your manuscript here.
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References
1. Carretero Hernández G, Puig L; en representación del Grupo de Psoriasis de la AEDV. The use of biosimilar drugs in psoriasis: a position paper. Actas Dermosifiliogr. 2015;106(4):249-51.
2. Medicamentos biocomparables para la psoriasis. Posicionamiento de la Academia Mexicana de Dermatología. García-Hidalgo L, Méndez-Flores S, Carrillo-Vázquez S, et al. Gac Med Mex. 2020;156(Supl):1-14.
3. GaBI Online - Generics and Biosimilars Initiative. Position statement on approval of biosimilars in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 19]. Available from: www.gabionline.net/Biosimilars/General/Position-statement-on-approval-of-biosimilars-in-Latin-America
4. Feijó Azevedo V, Babini A, Vieira Teixeira F. New monoclonal antibody biosimilars approved in 2015 in Latin America: position statement of the Latin American Forum on Biosimilars on biosimilarity, interchangeability and extrapolation of indications. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(2):66-9. doi:10.5639/gabij.2016.0502.017
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