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Cure8 news brief
Polpharma Biologics gains FDA and EMA review acceptances - PharmaTimes
Medications
Vedolizumab
Biosimilars
Anti Integrin
Regulatory Update
Adult patients
Patients On Biologics
Clinicians
Why This Matters
A vedolizumab biosimilar could increase access to an important biologic treatment for people with moderate‑to‑severe UC and Crohn’s disease by offering a potentially lower‑cost alternative. Regulatory review by the FDA and EMA are key steps toward possible future availability.
Who Should Pay Attention
Adults with moderate-to-severe ulcerative colitis or Crohn’s disease, patients currently on or considering vedolizumab (Entyvio) therapy, gastroenterology clinicians, and payers/interested policy advocates focused on biologic access.
Study Snapshot
Story typeCompany update
Evidence typeRegulatory update
Source depthFull source text
What To Know
FDA and EMA have accepted for review regulatory applications (BLA and MAA) for PB016, a proposed vedolizumab biosimilar for IV use in adults with moderately to severely active ulcerative colitis and Crohn’s disease. The programme includes analytical work, a phase 1 study in healthy volunteers and a phase 3 trial in ulcerative colitis patients.
Fresenius Kabi holds global commercialization rights outside the Middle East and North Africa.
Keep In Mind
Regulatory acceptance for review does not mean approval; the agencies will evaluate analytical, clinical and non‑clinical data before any decision. The article reports results of development-stage studies (phase 1 and a phase 3 in UC) but does not provide study outcomes or safety/effectiveness data.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Article type assigned from Cure8 classification; confirm details in the original source.
Publicationpharmatimes.com
AuthorsJohn Pinching
Indexed viaGoogle News
Source typeWeb article
PublishedAug 3, 2026, 4:20 PM
Content availableFull source text
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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