Drug Profile

Vedolizumab biosimilar - Polpharma Biologics

Alternative Names: PB-016

Latest Information Update: 26 Nov 2025

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At a glance

Originator Polpharma Biologics
Class Anti-inflammatories; Immunotherapies; Monoclonal antibodies
Mechanism of Action Integrin alpha4beta7 antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Phase I Immunological disorders
Clinical Phase Unknown Crohn's disease; Ulcerative colitis

Most Recent Events

14 Nov 2025 Phase-I clinical trials in Immunological disorders (In volunteers) in Germany (SC) (CTIS2025-522534-31-00)
02 Sep 2025 Vedolizumab biosimilar licensed to MS Pharma in Middle East & North Africa
05 Aug 2025 Vedolizumab biosimilar licensed to Fresenius Kabi worldwide, excluding Middle East & North Africa

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