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

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.