Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | ulcerative colitis | 2026-07-31 | “FDA) and European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and the Marketing Authorisation Application (MAA), respectively, for PB016” fresenius.com ↗ “FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016” fresenius-kabi.com ↗ |
| Filed | US (FDA) | — | ulcerative colitis | 2026-07-31 | “FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016” fresenius-kabi.com ↗ “FDA) and European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and the Marketing Authorisation Application (MAA), respectively, for PB016” fresenius.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05771155 | Jul 2023 → Sep 2025 overdue | ulcerative colitis | Polpharma Biologics S.A. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-07-31 | Fresenius Kabi | Regulatory Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate fresenius.com ↗
“FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. |
| 2026-07-31 | Fresenius Kabi | Regulatory Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate fresenius.com ↗
the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and the Marketing Authorisation Application (MAA), respectively, for PB016 |
| 2026-07-31 | Fresenius Kabi | Regulatory Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate
Fresenius Kabi announced that the FDA and EMA have accepted for review PB016, a proposed vedolizumab biosimilar candidate for adults with ulcerative colitis and Crohn’s disease. fresenius-kabi.com ↗
U.S. FDA acceptance for review of Biologics License Application (BLA) and European Medicines Agency (EMA) acceptance for review of the Marketing Authorization Application (MAA) of intravenous vedolizumab biosimilar candidate, an integrin receptor antagonist. |
| 2026-07-31 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate polpharmabiologics.com ↗
The BLA and MAA acceptances represent significant milestones in Polpharma Biologics’ development program and underscore the company’s commitment to advancing high-quality biosimilars and expanding global access to affordable biologic medicines. |
| 2024-02-21 | Polpharma Biologics S.A. | Results Polpharma Biologics’ investigational biosimilar shows PK/PD comparability to inflammatory bowel disease blockbuster Entyvio®* polpharmabiologics.com ↗
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. |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PB016 | “PB016 will be administered to patients with moderately to severely active UC on Weeks 0, 2 and 6, and once every 8 weeks thereafter, per the approved dosing regimen of Entyvio®” NCT05771155 ↗ |
| Route | Intravenous | “intravenous infusions of either PB016 or Entyvio® at a dose of 300 mg at Weeks 0 and 2” NCT05771155 ↗ |