Boehringer Ingelheim Report Results of BI 695501 in P-III Trial for Patients with Crohn’s Disease

Boehringer Ingelheim and Zealand Pharma to Initiate P-II Study of BI 456906 for Obesity and Diabetes


  • The P-III study involves assessing BI 695501 vs Abbvie’s Humira in 147 patients with mod. to sev. CD that were either TNF naïve or prior treated with infliximab
  • The P-III study results demonstrated non-inferior efficacy and similar safety profile to the reference product, met its 1Eps i.e, CDAI response @4wks. (89.7% vs 94.4%); infection rates (23.6% vs 22.7%); safety was similar b/w the group with no new safety signals
  • BI 695501 is biosimilar referencing AbbVie’s Humira, approved by the US FDA and EMA in 2017 as Cyltezo for multiple chronic inflammatory diseases

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