In February 2024, Polpharma Biologics (Polpharma) unveiled topline results demonstrating the PK and pharmacodynamic (PD) comparability of PB016, their biosimilar candidate for vedolizumab, with its reference drug, Entyvio, by Takeda Pharmaceutical.
Polpharma Biologics PK and PD study on vedolizumab
Polpharma Biologics’ results came from a single-dose, randomized, double-blind, 3-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.
Vedolizumab is a monoclonal antibody that targets the α4β7 integrin (alfa-4-beta-7 integrin), a protein found on gut homing T helper lymphocytes, reducing gastrointestinal inflammation. It is approved in the US and Europe as a treatment for moderate-to-severe cases of Ulcerative Colitis (UC) and Crohn’s disease, the two most common forms of inflammatory bowel disease (IBD); and additionally, for pouchitis in Europe [1-2].
On 27 September 2023, Takeda, the manufacturer of Entyvio (vedolizumab), announced the approval by the US FDA for the subcutaneous (SC) administration of Entyvio for maintenance therapy in adults with moderately to severely active UC after induction therapy with Entyvio intravenous (IV). Entyvio SC is available in the US as a single-dose pre-filled pen (Entyvio Pen). Additionally, a Biologics License Application for an investigational SC administration of Entyvio for the treatment of adults with moderately to severely active Crohn’s disease is currently under review by the FDA.
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References
1. Drug Trials Snapshot: Entyvio (vedolizumab) to Treat Ulcerative Colitis
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-entyvio-vedolizumab-treat-ulcerative-colitis
2. Entyvio (vedolizumab) EMA. https://www.ema.europa.eu/en/documents/overview/entyvio-epar-summary-public_en.pdf
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