Positive trial results for Polpharma’s Entyvio biosimilar for IBD

21 February 2024

Dutch firm Polpharma Biologics today announced top-line results demonstrating the pharmacokinetic (PK) and pharmacodynamics (PD) comparability of its biosimilar candidate PB016 to its reference drug, Entyvio (vedolizumab), as marketed by Japanese pharma major Takeda (TYO: 4502).

Results came from a single-dose, randomized, double-blind, three-arm parallel-group study assessing the PK/PD and immunogenicity for PB016 compared to Entyvio after intravenous administration in 120 healthy subjects. 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.

The company notes that PB016 will be Polpharma Biologics’ third biosimilar to enter late-stage development and today’s results show its potential as a more affordable future biologic option for the treatment of inflammatory bowel diseases (IBD).

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