Shots:

• 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

Click here Click here to read full press release/ article | Ref: empr- clinical trials | Image: Signbox