The evidence from clinical trials, complemented by real-world experience, has helped clarify concepts and significantly modified the use and positioning of biological agents in this context. This document is therefore an update of the position of the Spanish Psoriasis Group regarding the use of biosimilar drugs, taking into account this new situation. Specifically, the document is based on updated scientific evidence on the use of biosimilars in moderate-to-severe psoriasis, including numerous trials such as the EGALITY study, as well as reviews of positioning documents from other Spanish scientific societies such as Asociación Española de Bioempresas (ASEBIO), Sociedad Española de Oncología Médica (SEOM), Sociedad Española de Reumatología (SER) [2], Sociedad Española de Inflamación Ocular (SEIOC), and Sociedad Española de Farmacia Hospitalaria (SEFH) [3]. 

According to access regulations in Spain, the vast majority of patients with moderate to severe psoriasis who are not receiving biological treatment and who meet the requirements for it should start with a biosimilar (usually adalimumab), and a switch to adalimumab biosimilar was necessary for most patients receiving the originator adalimumab with an adequate response [3].

The updated positioning of the Spanish Psoriasis Group is summarized in the following conclusions:

1. A biosimilar drug is defined as one that contains a version of an active substance that has already been authorized as an original biotechnological drug (reference medicine) in the European Economic Area, whose patent rights have expired, and which complies with the principles established in the guidelines published by the European Medicines Agency (EMA).
2. When the active substance is a protein, it is expected that the amino acid sequence is the same and that the criteria of analytical biosimilarity and biological and therapeutic activity (equivalence studies) are met.
3. The demonstration of biosimilarity by the EMA, whose regulatory framework has been developed since 2004, requires the performance of comparative studies of quality, non-clinical comparative studies (pharmacodynamics, effects on physiological and cellular targets), and clinical studies (not for safety and efficacy in patients, which have already been demonstrated by the reference medicine): pharmacokinetic, pharmacodynamic, and, if applicable, clinical trials of equivalence of efficacy, safety, immunogenicity, and, if applicable, that allow extrapolation of indications.
4. The posology and route of administration of the biosimilar must be the same as those of the reference biological.
5. Any deviation regarding potency, pharmaceutical form, excipients, or presentation must be appropriately justified, and under no circumstances can compromise safety. Changes that involve an improvement in the efficacy of the biosimilar compared to the reference product are incompatible with the authorization of a biosimilar. However, those changes that include improvements in safety (such as a decrease in impurities or lower immunogenicity) must be notified and do not rule out biosimilarity.
6. The extrapolation of indications to the same ones as the reference biologic is based on the available data for each biosimilar and is the responsibility of EMA.
7. Interchangeability is the possibility of replacing a medication with another that is expected to have the same clinical effect. Until September 2022, the decision on the interchangeability of biosimilars was up to each state, but currently, the EMA and National Health Agencies consider that once a biosimilar is approved in the EU, it is considered interchangeable with its reference product and with other biosimilars of the same. According to the US Food and Drug Administration, interchangeability is only permitted from the reference drug to the biosimilar and vice versa, but not between biosimilars.
8. The interchangeability should be carried out at the discretion of the prescriber and/or based on agreements of the pharmacotherapeutic committees of the hospitals, under supervision and acceptance of the prescribers and informing the patient of the change.
9. The substitution (change from a biological drug to a biosimilar by the pharmacist without the intervention of the prescriber) is the responsibility of each state, and it is not authorized in Spain.
10. Biosimilars, which are comparable in efficacy, safety, and immunogenicity to the bio-original, focus their competition on cost reduction and therefore on improving efficiency. However, this efficiency should be supported by objective cost-effectiveness analyses, since it could happen that, in the case of an early switch after first-line use due to lack of efficacy or safety, the perspective of efficiency should be weighed against the cost of innovative drugs introduced in second-line. The GPS considers it necessary and timely to have these studies under appropriate methodological parameters.
11. The availability of efficient biosimilars with a good balance of effectiveness/safety should favour a paradigm shift that allows positioning this therapeutic group as first-line in moderate-to-severe forms of the disease that require systemic treatment.
12. The availability of biosimilars should not reduce the optimal therapeutic goals achievable for the disease at the present time or limit the use of other therapies that may allow achieving this objective.
13. The use of biosimilars as first-line treatment is appropriate in a high percentage of patients with moderate to severe forms of psoriasis who require biological therapy, mainly due to efficiency criteria. However, this circumstance must coexist with the evidence that other biological drugs with better efficacy and safety are available, as demonstrated by comparative clinical trials and meta-analyses. Thus, the possibility of using non-biosimilar biological drugs as first-line therapy should be available to physicians and patients in specific cases.
14. The proper introduction and management of biosimilar drugs in each center requires multidisciplinary coordination of resource management services, hospital pharmacy, clinical staff, clinical pharmacology, and nursing. In the Spanish healthcare system, biological drugs are MHDA (Hospital Dispensing Medicines) and their prescription and dispensing are restricted to the hospital setting, unlike in other areas of the EMA territory.
15. The benefits derived from the rational use of resources through the introduction of biosimilars should have an impact on the healthcare system through shared benefit strategies.
16. Finally, it would be advisable to standardize the scenarios in different autonomous communities, with different guidelines for access and restrictions on the use of biologicals for the treatment of psoriasis.
17. For reasons of efficiency, it is recommended to initiate treatment with biosimilars in most patients; in case of contraindication, adverse effect or insufficient therapeutic response, it should be possible to prescribe the most appropriate treatment according to the clinician's criteria, also taking into account efficiency criteria, regardless of the mechanism of action or pharmacological target.

Conflict of interest
Authors of the research paper [1] declared that there was various conflict of interest. For full details of the authors’ conflict of interest, see the research paper [1].

Editor’s comment
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Use of biologicals in dermatology – following the agreed path or going off-piste? A brief report

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References
1. Villaverde RR, Gutiérrez MG, Velasco ML, et al. Updated position of the Spanish Psoriasis Group (GPs) on the use of biosimilar drugs in moderate to severe psoriasis. Actas Dermo-sifiliograficas. 2023:S0001-7310(23)00172-2.
2. GaBI Online - Generics and Biosimilars Initiative. Spanish Society of Rheumatology issues position statement on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 14]. Available from: www.gabionline.net/biosimilars/general/Spanish-Society-of-Rheumatology-issues-position-statement-on-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Spanish pharmacists publish biosimilar position statement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 14]. Available from: www.gabionline.net/reports/Spanish-pharmacists-publish-biosimilar-position-statement
4. GaBI Online - Generics and Biosimilars Initiative. Drug survival of adalimumab biosimilars in psoriasis treatment in Spain [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 14]. Available from: www.gabionline.net/biosimilars/research/drug-survival-of-adalimumab-biosimilars-in-psoriasis-treatment-in-spain

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