Polpharma Biologics’ investigational biosimilar shows PK/PD comparability to inflammatory bowel disease blockbuster Entyvio®

Polpharma Biologics, announced topline results demonstrating the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of its biosimilar candidate PB016 to its reference drug, Entyvio®* (vedolizumab).

Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars, today announced topline results demonstrating the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of its biosimilar candidate PB016 to its reference drug, Entyvio®* (vedolizumab).

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. 

“We are excited to share new data showing the PK/PD comparability of our investigational vedolizumab biosimilar to its reference drug. The results confirm its potential as a more affordable future option for 3.5 million patients suffering from inflammatory bowel diseases in Europe and the US. As the frontrunner among biosimilar competitors, PB016 targets a market with over $5.3 billion in annual Entyvio®* sales, expected to grow to over $7 billion by 2030", said Konstantin Matentzoglu, member of the Supervisory Board and the executive management, Polpharma Biologics Group. “With two biosimilars from our pipeline already partnered with highly reputable companies, we are proud that PB016 is the next Polpharma Biologics therapy which has entered late-stage development. Ourscientists have developed it from cell line development to full-scale manufacturing in-house, an optimal position for securing future commercial partnerships for this asset.”

Polpharma Biologics is currently conducting a global clinical safety & efficacy study in patients with ulcerative colitis (UC) to provide further evidence on the efficacy, safety and immunogenicity of PB016, as compared to the reference drug.

Vedolizumab is a monoclonal antibody that targets the α4β7 integrin, a protein found on gut homing T helper lymphocytes, reducing gastrointestinal inflammation.1 It is approved in the US and Europe as a treatment for moderate-to-severe cases of UC and Crohn’s disease2,3 - the two most common forms of inflammatory bowel disease (IBD) - and additionally for pouchitis in Europe.3 Vedolizumab is also approved in over 70 countries worldwide, including Japan, Canada, and Australia, though its approved uses may vary. These chronic bowel conditions affect over 3.5 million people in Europe and the US, often significantly impacting patients’ daily functioning and quality of life.4 Factors like genetics and increasing urbanization may be contributing to growing prevalence of these diseases.5

Polpharma Biologics is focused on broadening access to biological medicines used to treat some of the world’s most impactful diseases across neurology, immunology, and ophthalmology. The company is at the forefront of the next wave in biopharma, leveraging its knowledge, capabilities, and footprint to develop its robust pipeline of more than seven biosimilarsin early-late-stage development.

*Entyvio® is a trademark of Takeda Pharmaceutical Company Limited.