PB016 (vedolizumab biosimilar) / Polpharma, Fresenius Kabi, MS Pharma - LARVOL DELTA

PHARMACOKINETICS, IMMUNOGENICITY, AND Α4Β7 RECEPTOR SATURATION, FOR PB016 VERSUS US-LICENSED AND EU-APPROVED ENTYVIO® AFTER INTRAVENOUS ADMINISTRATION IN HEALTHY SUBJECTS - A SINGLE DOSE, RANDOMIZED, DOUBLE-BLIND 3-ARM PARALLEL-GROUP STUDY (UEGW 2026) - "We here demonstrate PK-PD similarity for PB016, AU-Ref and US-Ref. All primary and secondary endpoints were met. Immunogenicity and safety profiles were similar across the three treatment groups."

Clinical • PK/PD data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate (Businesswire) - "PB016 has been studied in a Phase 1 trial with healthy volunteers and a Phase 3 trial with ulcerative colitis patients (NCT05771155)."

EMA filing • FDA filing • Ulcerative Colitis

PB016-01-02: A single dose, randomized, double-blind 2-arm parallel-group study to compare the pharmacokinetics, immunogenicity, and safety for PB016 versus US-licensed Entyvio after subcutaneous administration in healthy participants (clinicaltrialsregister.eu) - P1 | N=132 | Recruiting | Sponsor: Polpharma Biologics S.A.

New P1 trial

Polpharma Biologics S.A…announced that it has signed licensing agreements with MS Pharma…for the commercialization of its biosimilar candidates vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) in the MENA region. (Businesswire) - "Under the agreements, MS Pharma will be responsible for the registration, marketing, and distribution of these three biosimilars across MENA, while Polpharma Biologics will maintain responsibility for development, manufacturing, and supply. Furthermore, both Parties have agreed to transfer fill and finish activities to the MENA region."

Commercial • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Polpharma Biologics and Fresenius Kabi Sign Licensing Agreement for Proposed Vedolizumab Biosimilar PB016 (Businesswire) - "Polpharma Biologics...announces a global (except for Middle East & North Africa) licensing agreement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab, an integrin receptor antagonist, (reference product: Entyvio), a biologic therapy indicated for moderate to severe ulcerative colitis and Crohn’s disease. Under the terms of the agreement, Polpharma Biologics will lead development and manufacturing of PB016, while Fresenius Kabi will hold exclusive commercialization rights worldwide, excluding Middle East & North Africa....The agreement builds on Polpharma Biologics’ growing biosimilar portfolio and proven development capabilities."

Licensing / partnership • Crohn's disease • Ulcerative Colitis

UCESIVE: Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio® (clinicaltrials.gov) - P3 | N=750 | Active, not recruiting | Sponsor: Polpharma Biologics S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

UCESIVE: Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio® (clinicaltrials.gov) - P3 | N=750 | Recruiting | Sponsor: Polpharma Biologics S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Polpharma Biologics' investigational biosimilar shows PK/PD comparability to inflammatory bowel disease blockbuster Entyvio (PRNewswire) - P=NA | N=NA | "Polpharma Biologics...announced topline results demonstrating the pharmacokinetic (PK) and pharmacodynamics (PD) comparability of its biosimilar candidate PB016 to its reference drug, Entyvio (vedolizumab)....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.

Clinical data • PK/PD data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

UCESIVE: Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio® (clinicaltrials.gov) - P3 | N=750 | Not yet recruiting | Sponsor: Polpharma Biologics S.A.

New P3 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Solid Tumor • Ulcerative Colitis