1. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects. (1st December 2016) Authors: Wynne, Christopher; Altendorfer, Mario; Sonderegger, Ivo; Gheyle, Lien; Ellis-Pegler, Rod; Buschke, Susanne; Lang, Benjamin; Assudani, Deepak; Athalye, Sandeep; Czeloth, Niklas Journal: Expert opinion on investigational drugs Issue: Volume 25:Number 12(2016:Dec.) Page Start: 1361 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext). (3rd October 2019) Authors: Cohen, Stanley B.; Czeloth, Niklas; Lee, Eric; Klimiuk, Piotr A.; Peter, Nuala; Jayadeva, Girish Journal: Expert opinion on biological therapy Issue: Volume 19:Number 10(2019) Page Start: 1097 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study. (2nd January 2021) Authors: Menter, Alan; Arenberger, Petr; Balser, Sigrid; Beissert, Stefan; Cauthen, Ashley; Czeloth, Niklas; Soung, Jennifer; Jazayeri, Sasha; Weisenseel, Peter; Jayadeva, Girish Journal: Expert opinion on biological therapy Issue: Volume 21:Number 1(2021) Page Start: 87 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. A specific CD4 epitope bound by tregalizumab mediates activation of regulatory T cells by a unique signaling pathway. Issue 4 (16th December 2014) Authors: Helling, Bianca; König, Martin; Dälken, Benjamin; Engling, Andre; Krömer, Wolfgang; Heim, Katharina; Wallmeier, Holger; Haas, Jürgen; Wildemann, Brigitte; Fritz, Brigitte; Jonuleit, Helmut; Kubach, Jan; Dingermann, Theodor; Radeke, Heinfried H; Osterroth, Frank; Uherek, Christoph; Czeloth, Niklas... Journal: Immunology and cell biology Issue: Volume 93:Issue 4(2015) Page Start: 396 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects. (3rd August 2017) Authors: Hettema, Willem; Wynne, Christopher; Lang, Benjamin; Altendorfer, Mario; Czeloth, Niklas; Lohmann, Ragna; Athalye, Sandeep; Schliephake, Dorothee Journal: Expert opinion on investigational drugs Issue: Volume 26:Number 8(2017) Page Start: 889 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗