Biosimilars for skin conditions safe and effective

Biosimilares/Investigación | Posted 14/05/2021 post-comment0 Post your comment

Two recently published articles [1, 2] assessing the use of biosimilars for the long-term skin conditions psoriasis and hidradenitis suppurativa indicate that biosimilar treatments are equally as effective as the originator, demonstrating similar drug retention and clinical response rates, respectively. 

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As many skin conditions have an immune component, biological drugs targeting inflammatory molecules can be effective treatment options. Biological drugs that have been approved for dermatological conditions include adalimumab, etanercept, infliximab and rituximab. However, many originator biological drugs are unaffordable, and data suggest large proportions of patients go untreated – one study in the US showed that conventional biological treatments were used by less than 20% of patients with severe psoriasis [3].

Biosimilar drugs play an important role in reducing costs and increasing access to these treatments, and two papers recently published in JAMA Dermatology demonstrate the real-world effectiveness of biosimilars for dermatological complaints.

The first study [1] looked at outcomes following a switch from originator adalimumab to a biosimilar version. Adalimumab, sold as Humira by the originator company AbbVie, is an inhibitor of the inflammatory molecule tumour necrosis factor (TNF). It is administered by subcutaneous injection and on WHO’s List of Essential Medicines.

The study assessed outcomes following a switch to biosimilar adalimumab in patients with psoriasis in Denmark. Psoriasis is a long-term skin condition with an autoimmune origin. Biosimilars of infliximab and etanercept have been approved and used for the treatment of psoriasis since 2013 and 2016, respectively, and a number of adalimumab biosimilars have recently been approved to treat the condition.

Denmark implemented a non-medical, mandatory switch of all adults with psoriasis treated with originator adalimumab to a biosimilar version in November 2018 – a policy which has been shown to reduce costs by more than 80% [4].

The researchers studied a Danish nationwide registry of all patients treated with biologicals (including biosimilars) for psoriasis. The biosimilar cohort included patients who switched from originator adalimumab to an adalimumab biosimilar between November 2018 and May 2019, while the originator cohort included patients treated with an adalimumab originator between May 2017 and November 2017. More than 700 patients were included in the study in total.

The results showed no significant difference in 1-year drug retention rates between cohorts (92% for the biosimilar cohort, compared to 92.1% for the originator cohort). There were also no significant differences in hazard ratios between cohorts, indicating that biosimilar adalimumab has similar effectiveness and safety to the originator. However, use of biosimilar adalimumab was associated with more dermatologic adverse events than the originator, something the authors say warrants further study.

The second study [2] focused on infliximab, which is also a TNF inhibitor and has been marketed as Remicade by originator company Johnson & Johnson. Infliximab can be used to treat a number of autoimmune conditions, including the skin condition hidradenitis suppurativa, which is characterized by painful abscesses.

The study evaluated the effectiveness of biosimilar infliximab (infliximab-abda) compared to the originator product in 34 people with hidradenitis suppurativa in the US. Infliximab-abda has been approved by the US Food and Drug Administration (FDA) for the treatment of a number of inflammatory conditions.

Patients were treated between 2016 and 2020 at the University of North Carolina at Chapel Hill dermatology clinic. Of these, 59% received originator infliximab and 41% received the biosimilar version. Patients were tracked for at least 10 weeks following treatment initiation using their electronic medical records.

The analysis showed no significant difference in the proportion of patients achieving clinical response (defined as at last a 50% decrease in inflammatory nodule count, without any increase in abscesses or draining sinuses) between groups. In the biosimilar group, 71% of patients achieved clinical response, compared to 60% in the originator group. This study provides evidence to suggest that infliximab-abda is equally as effective as the originator product, although the sample sizes used in the study were small.

Despite the limitations of the studies, they provide important evidence to suggest that biosimilars are just as effective as their originator counterparts in the treatment of dermatological conditions. This is important as the use of biosimilars could drastically increase access to treatment for people with skin diseases; an issue which is particularly important in the US, where prices for biological drugs are notoriously high.

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LATIN AMERICAN FORUM – Coming soon!

To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

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LATIN AMERICAN FORUM – Próximamente!

Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

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References
1. Loft N, Egeberg A, Rasmussen M, et al. 2021. Outcomes following a mandatory nonmedical switch from adalimumab originator to adalimumab biosimilars in patients with psoriasis. JAMA Dermatol. 2021 Apr 7.
2. Westerkam L, Tackett K, Sayed C. Comparing the effectiveness and safety associated with infliximab vs infliximab-abda therapy for patients with hidradenitis suppurativa. JAMA Dermatol. 2021 Apr 7.
3. Lebwohl MG, Kavanaugh A, Armstrong AW, et al. US perspectives in the management of psoriasis and psoriatic arthritis: patient and physician results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. Am J Clin Dermatol. 2016;17(1):87-97.
4. GaBI Online - Generics and Biosimilars Initiative. Denmark achieves 83% reduction in adalimumab costs through switching [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 14]. Available from: www.gabionline.net/Biosimilars/Research/Denmark-achieves-83-reduction-in-adalimumab-costs-through-switching

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