Polpharma Biologics has announced that the FDA and EMA have accepted for review the BLA and MAA for PB016, a proposed vedolizumab biosimilar to Entyvio for intravenous use in adults with moderately to severely active ulcerative colitis and Crohn’s disease.
The acceptances mark major milestones in the company’s development programme and reinforce its commitment to expanding access to affordable biologic medicines.
The FDA and EMA reviews cover PB016 in lyophilised vial form for intravenous administration. The biosimilar was developed and will be manufactured by Polpharma Biologics, while Fresenius Kabi holds exclusive global commercialisation rights excluding the Middle East and North Africa.
Anjan Selz, CEO of Polpharma Biologics International AG, said: “FDA and EMA acceptances for review of our IV vedolizumab biosimilar candidate mark a major achievement for Polpharma Biologics and validate our deep scientific expertise in biosimilar development and manufacturing. PB016 represents the culmination of rigorous development work across our integrated platform – from cell line development through comprehensive clinical studies.”
He added: “We are proud to deliver this important therapeutic option in partnership with Fresenius Kabi, an operating company of Fresenius, whose global commercialization capabilities will ensure patients worldwide gain access to high-quality, affordable treatment for chronic inflammatory diseases.”
PB016 is a proposed biosimilar to vedolizumab, an integrin receptor antagonist indicated for adults with moderately to severely active ulcerative colitis and Crohn’s disease. The biosimilar development programme was designed to demonstrate high similarity to the reference product through analytical, non‑clinical and clinical studies.
PB016 has been evaluated in a phase 1 trial with healthy volunteers and a phase 3 trial in ulcerative colitis patients. IBD affects millions of patients in the US and Europe and is a chronic condition that can significantly impact long‑term quality of life.
In this context biosimilars have strong potential to broaden access to effective biologic therapies.
