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.