Netherland-based Polpharma Biologics has released topline results from a pharmacokinetic (PK) and pharmacodynamic (PD) study of its biosimilar candidate PB016, showing that the biosimilar is non-inferior to its reference biologic, Takeda Pharmaceuticals’ Entyvio (vedolizumab).
Entyvio is an α4β7 integrin targeting monoclonal antibody that helps in reducing gastrointestinal inflammation. It was approved to treat inflammatory bowel disease (IBD), namely ulcerative colitis (UC) and Crohn’s disease, by the US Food and Drug Administration (FDA) in 2014. The therapy generated Y936.1bn ($6.2bn) in the first nine months of 2023, as per Takeda’s Q3 financials.
The PK and PD study evaluated the efficacy, safety and immunogenicity of PB016 in comparison with Entyvio in 120 healthy participants. PB016 was comparable to Entyvio across pharmacokinetic and pharmacodynamic parameters. Furthermore, there were no immunogenicity or safety imbalances between the two therapies.
Polpharma is also investigating PB016 in a Phase III trial (NCT05771155) against Entyvio in UC patients. The study is expected to enrol 750 participants and will conclude in September 2025, as per ClinicalTrials.gov.
The IBD market is predicted to grow in the next decade, and GlobalData estimates that the Crohn’s and UC markets will be worth approximately $14.9bn and $11.2bn by 2032. The global sales of Entyvio are projected to reach $7.9bn by 2029, as per GlobalData's market analysis.
GlobalData is the parent company of Clinical Trials Arena.
Takeda has also invested in sustaining and increasing revenue generated by Entyvio. The company developed a subcutaneous formulation of the monoclonal antibody, which was approved by the US FDA as a maintenance therapy to treat moderately to severely active UC in adults following induction therapy with intravenous Entyvio in September 2023.
Another biosimilar developed by Polpharma is Biogen’s Tysabri (natalizumab) biosimilar, Tyruko. The biosimilar is licensed to Sandoz, which bears responsibility for distribution and commercialisation. Tyruko was approved by the FDA for all multiple sclerosis (MS) settings where Tysabri is currently used, including relapsing-remitting MS, clinically isolated syndrome (CIS), and active secondary progressive disease, in addition to Crohn’s disease in August 2023.
