Real-world evidence – biosimilars can successfully substitute biologics in psoriasis and hidradenitis suppurativa

Joanna Wegner; Karolin Groß; Yalda Ghoreishi; Julia Hinkel; Berenice M. Lang; Caroline Mann; Michael Schultheis; Wiebke Kaluza-Schilling; Andreas Schwarting; Petra Staubach

doi:10.5114/ada.2025.153333

eISSN: 2299-0046
ISSN: 1642-395X

Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii

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5/2025
vol. 42

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abstract:

Original paper

Real-world evidence – biosimilars can successfully substitute biologics in psoriasis and hidradenitis suppurativa

Joanna Wegner

^{1, 2}

,

Karolin Groß

¹

,

Yalda Ghoreishi

^{1, 2}

,

Julia Hinkel

^{1, 2}

,

Berenice M. Lang

^{1, 2}

,

Caroline Mann

^{1, 2}

,

Michael Schultheis

^{1, 2}

,

Wiebke Kaluza-Schilling

³

,

Andreas Schwarting

^{2, 4}

,

Petra Staubach

^{1, 2}

Department of Dermatology, University Medical Center, Mainz, Germany
Universitäres Centrum für Autoimmunität (UCA), University Medical Center, Mainz, Germany
Rheumapraxis, Mainz, Germany (private practice)
Department of Rheumatology, University Medical Center, Mainz, Germany

Adv Dermatol Allergol 2025; XLII (5): 488–493

DOI: https://doi.org/10.5114/ada.2025.153333

Online publish date: 2025/07/15

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AMA

Wegner J, Groß K, Ghoreishi Y, et al. Real-world evidence – biosimilars can successfully substitute biologics in psoriasis and hidradenitis suppurativa. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii. 2025;42(5):489-493. doi:10.5114/ada.2025.153333.

APA

Wegner, J., Groß, K., Ghoreishi, Y., Hinkel, J., Lang, B.,  & Mann, C. et al. (2025). Real-world evidence – biosimilars can successfully substitute biologics in psoriasis and hidradenitis suppurativa. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, 42(5), 489-493. https://doi.org/10.5114/ada.2025.153333

Chicago

Wegner, Joanna, Karolin Groß, Yalda Ghoreishi, Julia Hinkel, Berenice M. Lang, Caroline Mann,  and Michael Schultheis et al. 2025. "Real-world evidence – biosimilars can successfully substitute biologics in psoriasis and hidradenitis suppurativa". Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii 42 (5): 489-493. doi:10.5114/ada.2025.153333.

Harvard

Wegner, J., Groß, K., Ghoreishi, Y., Hinkel, J., Lang, B., Mann, C., Schultheis, M., Kaluza-Schilling, W., Schwarting, A.,  and Staubach, P. (2025). Real-world evidence – biosimilars can successfully substitute biologics in psoriasis and hidradenitis suppurativa. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, 42(5), pp.489-493. https://doi.org/10.5114/ada.2025.153333

MLA

Wegner, Joanna et al. "Real-world evidence – biosimilars can successfully substitute biologics in psoriasis and hidradenitis suppurativa." Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, vol. 42, no. 5, 2025, pp. 489-493. doi:10.5114/ada.2025.153333.

Vancouver

Wegner J, Groß K, Ghoreishi Y, Hinkel J, Lang B, Mann C et al. Real-world evidence – biosimilars can successfully substitute biologics in psoriasis and hidradenitis suppurativa. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii. 2025;42(5):489-493. doi:10.5114/ada.2025.153333.

Introduction:
Medical approval of biosimilars requires comparable quality, biological activity, safety as well as efficacy of the reference biologic drug.

Aim:
The aim of this study is to examine whether biosimilars for adalimumab and etanercept can be prescribed as substitutes for the originator drugs in a real-world patient collective.

Material and methods:
For the analysis, 259 outpatients with psoriasis (94%) or hidradenitis suppurativa (6%) were retrospectively examined regarding disease burden, side effects and symptoms during and following the transition from a biologic to a biosimilar and, if applicable, after switching back to the originator drug.

Results:
Of the analysed cohort, 76.4% of patients had previously received the adalimumab originator, Humira^®, and 23.6% the etanercept originator, Enbrel^®. 79.5% of those patients were switched to a biosimilar. In that group, 94.2% of patients returned for a follow-up visit (after 3 to 9 months), with 78.9% of them continuing the biosimilar therapy until the end of the observation period. 21.1% of all patients were switched back to the original treatment or another medication due to various reasons, such as deterioration of efficacy (68.3%), progression of arthritis (68.3%) and increased skin symptoms (56.1%).

Conclusions:
This real-world data shows that biosimilar therapy is successful in around 80% of the population observed. In the event of exacerbation of symptoms or occurrence of side effects, switching back to the biologic might be necessary and was proved to be problem-free.

keywords:

Real-world evidence – biosimilars can successfully substitute biologics in psoriasis and hidradenitis suppurativa

Joanna Wegner 1, 2 , Karolin Groß 1 , Yalda Ghoreishi 1, 2 , Julia Hinkel 1, 2 , Berenice M. Lang 1, 2 , Caroline Mann 1, 2 , Michael Schultheis 1, 2 , Wiebke Kaluza-Schilling 3 , Andreas Schwarting 2, 4 , Petra Staubach 1, 2

psoriasis, hidradenitis suppurativa, biologics, biosimilars

Joanna Wegner

^{1, 2}

,

Karolin Groß

¹

,

Yalda Ghoreishi

^{1, 2}

,

Julia Hinkel

^{1, 2}

,

Berenice M. Lang

^{1, 2}

,

Caroline Mann

^{1, 2}

,

Michael Schultheis

^{1, 2}

,

Wiebke Kaluza-Schilling

³

,

Andreas Schwarting

^{2, 4}

,

Petra Staubach

^{1, 2}