A recent paper by Spanish dermatologists reviews the principles of biosimilarity and equivalence trials that have led to the approval of the available adalimumab biosimilars . Given the current sophistication of the analytical processes, the need to include therapeutic equivalence trials for some drug classes might be eventually waived, but they are currently standard. Equivalence trials are designed to establish that the efficacy and safety of the biosimilar are similar to those of the reference biological, with a predetermined margin of equivalence that in psoriasis ranges from ±14% to ±18%. Lower margins would imply potentially unaffordable sizes of treatment groups. The primary endpoint of the study and the timing of the determination may or may not be the same as those used in the pivotal trials of the reference biological, but the number of patients included is intentionally lower; the statistical design of equivalence trials is currently the subject of active research. In many equivalence studies, biosimilars obtain response rates higher than those reported in the pivotal studies for the originator, probably because of the absence of a placebo arm, which would tend to raise researchers’ and patients’ efficacy expectations.
Independent studies are not required for each indication of the reference biological provided the agencies’ criteria for interchangeability are met. Equivalence clinical trials confirm biosimilarity as regards safety and immunogenicity within the predefined margin of equivalence, although variations in the excipients used may justify some minor differences, unlikely to be clinically relevant. Most equivalence trials of tumour necrosis factor alfa (TNF-α) inhibitors include an extension study, involving a single switch from originator to biosimilar or a crossover design with randomization and single or multiple cross-switches. Although the size and duration of these studies may not be sufficient to detect possible differences, there is scientific evidence supporting the efficacy and safety of interchanges, even between biosimilars. This provides the basis for eventual exchange of biosimilars solely based on variations in local financial agreements.
The introduction of adalimumab biosimilars in the European market in 2019 has had a tidal effect on the prescription of biologicals for patients with psoriasis . Competency-based price reductions have enhanced patients’ access to biological treatments, but the need for new biologicals with superior efficacy and safety remains. The benefits of the use of adalimumab biosimilars are based exclusively on their lower cost and greater competition, which improve as the acquisition price decreases under the effect of competition. Adalimumab biosimilars should facilitate access to biological therapies for all patients requiring systemic treatment, but payers’ intervention limits clinicians’ freedom to make appropriate prescription decisions and puts strain on the relationship between stakeholders. The objectives of all parties involved should be aligned with the common goal of offering the best treatment options, based on efficacy rather than solely on cost, minimizing the burden of psoriasis without impairing patients’ safety. In many cases, this will require first-line treatment with the available biosimilars (or originator drugs that offer similar efficacy), leaving subsequent lines of treatment to be decided by the specialist, but in other cases prescribers should not be prevented from using originators as first-line biologicals.
Conflict of interest
The authors of the research paper  reported conflict of interest, including having received fees as a consultant and/or speaker and having participated in clinical trials sponsored by pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper .
Abstracted by Luis Puig, MD, Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Readers interested to learn more about adalimumab biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods
Importance of manufacturing consistency of the glycosylated monoclonal antibody adalimumab (Humira®) and potential impact on the clinical use of biosimilars
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1. Puig L, Carrascosa JM, Notario J. Biosimilares en el tratamiento de la psoriasis. Actualización. Actas Dermosifiliogr. 2020;111(10):809-14.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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