Spanish Psoriasis Working Group Revises Guidelines for Biosimilars in Psoriasis

After a decade of biosimilar competition in the Spanish dermatology space, the Spanish Psoriasis Working Group (Grupo Español de Psoriasis) updated its position on the use of biosimilars in patients with moderate to severe psoriasis.

The new position addresses the data and market experience collected over time in Spain with regard to some of the biggest concerns providers and patients have about biosimilars, including first-line treatment and the safety of nonmedical switching.

The first biosimilars to receive approval from the European Medicines Agency (EMA) for use in immune-mediated diseases occurred in February 2013 (infliximab; Inflectra/Remsima). When the EMA approves a biosimilar, the Spanish Ministry of Health must also submit a favorable financing resolution and the Interministerial Pricing Commission sets the price of the product.

The authors made several position statements and recommendations, including the following:

• Providers should take into account efficiency data and objective cost-effectiveness data before prescribing a biosimilar
• It is appropriate to prescribe biosimilars as first-line therapies in the management of moderate to severe psoriasis
• The correct introduction and management of biosimilars requires multidisciplinary coordination in the resource management department, hospital pharmacists, clinicians, clinical pharmacology, and nursing services, especially because biosimilars are restricted to the hospital setting in Spain
• Health systems across the country should standardize their guidelines and restrictions for the use of biologics for psoriasis
• Physicians should be able to prescribe the most appropriate treatment for their patients at their discretion irrespective of whether a biosimilar option exists

The Spanish Psoriasis Working Group also addressed position papers from other Spanish scientific societies for providers to compare; however, the authors noted that some organizations may be outdated as they may not take into account more recent developments following the incorporation of biosimilars into clinical practice in Spain.

Although data from clinical trials are used by the EMA for approval, in some cases, safety and efficacy data are “insufficient to support definitive conclusions” about the safety of switching between the reference product and a biosimilar, according to the authors. Some studies have shown high rates of treatment discontinuation as a result of a nonmedical switch. However, the nocebo effect due to inadequate patient education on biosimilars is often to blame for worsened clinical outcomes.

Additionally, differences in drug composition and administration devices can lead to lower tolerability of a biosimilar vs the originator. The authors cited adalimumab as an example, where all but 1 of the adalimumab biosimilars on the market have excipients that contain citrate, acetate, or lactate, which many patients are not able to tolerate.

To instill greater patient acceptance and provider confidence regarding biosimilars, the authors said that “training programs are needed to resolve the doubts of professionals involved in the use of biosimilars and to draw up joint ‘shared benefit’ strategies involving management, pharmacy personnel, and the clinical professionals involved in the efficient management of biologic therapies.”

The authors emphasized the importance of real-world data, noting that only 21% to 31% of patients on the Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm) and the German Registry for Biological Treatment of Rheumatoid Arthritis meet the criteria for inclusion in clinical trials.

“This means that evidence from registries and real-life clinical studies have greater external validity and applicability than clinical trial data in terms of what we might expect to encounter in clinical practice.”

Furthermore, recent data on the use of biosimilars in psoriasis among 17 Spanish hospitals included patients whose disease was well controlled with the reference product prior to switching to a biosimilar, meaning that the Psoriasis Area Severity Index scores of patients enrolled in clinical trials is often lower than most patients in real-world settings looking to use a biosimilar. The authors recommended that real-world data should be evaluated along with clinical trial results to determine whether a patient would be successful on a biosimilar.

Data from the Spanish national health system (Sistema Nacional de Salud) showed that biologics account for half of total hospital spending on pharmaceuticals, noting that biosimilars present a good opportunity to save money. However, the presence of biosimilar competition in a particular market should not prevent providers from prescribing innovator drugs without biosimilars in cases where a patient with more severe disease may benefit.

Reference

Ruiz-Villaverde R, Galán-Gutiérrez M, Llamas-Velasco M, et al. [Translated article] Updated position of the Spanish Psoriasis Group (GPs) on the use of biosimilar drugs in moderate to severe psoriasis. Actas Dermosifiliogr. 2023;114(6):294-501. doi:10.1016/j.ad.2023.02.022