Polish biotechnology firm Polpharma Biologics has announced positive results from a comparability study for its late-stage biosimilar candidate PB016, which references Takeda’s (TYO: 4502) inflammatory bowel disease (IBD) blockbuster Entyvio (vedolizumab). The study’s data indicate that PB016 demonstrates similar pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety profiles compared to the reference product, both being α4β7 integrin inhibitors.
PB016 is currently in a trial assessing its efficacy in ulcerative colitis (UC), a prevalent form of IBD. With these positive results, Polpharma positions itself at the forefront of the competition to challenge Entyvio, a drug that generates annual sales of USD 5.3 billion and is projected to exceed USD 7 billion by 2030.
Takeda’s Entyvio, developed for UC, Crohn’s disease, and pouchitis, has garnered regulatory approvals across over 70 markets since its launch in 2014. The success of Polpharma’s biosimilar candidate could potentially disrupt the market dynamics for IBD treatments.- Flcube.com
