Topline results for Polpharma Biologics’ vedolizumab biosimilar candidate

Biosimilares/Investigación | Posted 16/04/2024 post-comment0 Post your comment

In February 2024, Polpharma Biologics (Polpharma) unveiled topline results demonstrating the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of PB016, their biosimilar candidate for vedolizumab, with its reference drug, Entyvio, by Takeda Pharmaceutical.

Pharmacokinetics 1 V13K15

Polpharma Biologics PK and PD study on vedolizumab
Polpharma Biologics’ results came from a single-dose, randomized, double-blind, 3-arm parallel-group study assessing the PK/PD and immunogenicity for PB016 compared to Entyvio after intravenous administration in 120 healthy subjects. 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.

Vedolizumab is a monoclonal antibody that targets the α4β7 integrin (alfa-4-beta-7 integrin), a protein found on gut homing T helper lymphocytes, reducing gastrointestinal inflammation.  It is approved in the US and Europe as a treatment for moderate-to-severe cases of ulcerative colitis (UC) and Crohn’s disease, the two most common forms of inflammatory bowel disease (IBD); and additionally, for pouchitis in Europe [1-2].

On 27 September 2023, Takeda, the manufacturer of Entyvio (vedolizumab), announced the approval by the  US Food and Drug Administration (FDA) for the subcutaneous (SC) administration of Entyvio for maintenance therapy in adults with moderately to severely active UC after induction therapy with Entyvio intravenous (IV). Entyvio SC is available in the US as a single-dose pre-filled pen (Entyvio Pen). Additionally, a Biologics License Application for an investigational SC administration of Entyvio for the treatment of adults with moderately to severely active Crohn’s disease is currently under review by the FDA.

Related articles
EMA recommends approval of first natalizumab biosimilar Tyruko for MS

Celltrion: Takeda acquisitions and new plant development

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Se lanza la Estrategia de Certidumbre Regulatoria para biosimilares en México

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Se lanza la Estrategia de Certidumbre Regulatoria para biosimilares en México

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

 

References
1. US Food and Drug Administration. Drug Trials Snapshot: Entyvio (vedolizumab) to treat ulcerative colitis [homepage on the Internet]. [cited 2024 Apr 16]. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-entyvio-vedolizumab-treat-ulcerative-colitis
2. European Medicines Agency. Entyvio (vedolizumab) [homepage on the Internet]. [cited 2024 Apr 16]. Available from: https://www.ema.europa.eu/en/documents/overview/entyvio-epar-summary-public_en.pdf

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.

 

comment icon Comments (0)
Post your comment
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010