PB016 (vedolizumab biosimilar) / Genefar - LARVOL DELTA

UCESIVE: Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio® (clinicaltrials.gov) - P3 | N=750 | Active, not recruiting | Sponsor: Polpharma Biologics S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

UCESIVE: Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio® (clinicaltrials.gov) - P3 | N=750 | Recruiting | Sponsor: Polpharma Biologics S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Polpharma Biologics' investigational biosimilar shows PK/PD comparability to inflammatory bowel disease blockbuster Entyvio (PRNewswire) - P=NA | N=NA | "Polpharma Biologics...announced topline results demonstrating the pharmacokinetic (PK) and pharmacodynamics (PD) comparability of its biosimilar candidate PB016 to its reference drug, Entyvio (vedolizumab)....PB016 was found to show comparability to Entyvio in all investigated PK and PD parameters, with no immunogenicity or safety imbalances to the reference drug.

Clinical data • PK/PD data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

UCESIVE: Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio® (clinicaltrials.gov) - P3 | N=750 | Not yet recruiting | Sponsor: Polpharma Biologics S.A.

New P3 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Solid Tumor • Ulcerative Colitis