Hanauer S, Liedert B, Balser S, et al. - BI 695501 (a biosimilar) vs adalimumab reference product have similar safety and efficacy in treating Crohn's disease. Thus, BI 695501 can be used as an alternative to adalimumab reference product for Crohn's disease treatment and is backed for other indications for which it is approved.

• A phase 3, randomised, double-blind study with 147 patients (aged 18–80 years) suffering from moderately to severely active Crohn's disease.

• Patients were randomized to BI 695501 (n=72) or adalimumab reference product (n=75).

• A clinical response at week 4 was evident in 90% and 94% of patients in the BI 695501 and adalimumab reference product groups, respectively.

• Patients taking adalimumab reference product when switched to BI 695501 exhibited maintained treatment benefits.

• During weeks 0–24, an adverse event occurred in 63% and 56% of patients in the BI 695501 group and in the adalimumab reference product group, respectively; 43% and 45% had adverse events during weeks 24–56, respectively.

• In BI 695501 and adalimumab reference groups, serious adverse events occurred in 8% and 11% of patients, respectively, between weeks 0–24, and two (3%) and nine (12%) patients between weeks 24–56, respectively.