EMA recommends approval of bevacizumab biosimilar Vegzelma

Biosimilares/Novedades | Posted 01/07/2022 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 June 2022 that it had recommended granting marketing authorization for the bevacizumab biosimilar Vegzelma.

Bevacizumab 1 V14f01

During the CHMP’s meeting of 20–23 June 2022, the committee recommended that Vegzelma receives a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer and carcinoma of the cervix.

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor-alpha (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers including colorectal, lung, breast, glioblastoma, kidney and ovarian cancers. The originator product, Avastin, is sold by Roche/Genentech.

Vegzelma (CT-P16) is produced by South Korean biotechnology company Celltrion. The company has already received approval for five other biosimilars in Europe [1]. Once approved, Vegzelma will be Celltrion’s third therapeutic oncology biosimilar. This says Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare, shows the company’s ‘ongoing commitment to bringing high quality and innovative biosimilars to the market, providing additional treatment options for people living with cancers’.

The positive CHMP opinion was supported by a comprehensive data package and totality of evidence demonstrating biosimilarity to the reference product (Avastin) for indications including metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.

There are already eight bevacizumab biosimilars approved in Europe [1]. Celltrion has also applied for marketing approval for its bevacizumab biosimilar (CT-P16) in Korea and the US [2].

Related article
Biosimilars of bevacizumab

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 last week’s headline article: Estado actual de los biosimilares de anticuerpos monoclonales aprobados en América Latina

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.

LATIN AMERICAN FORUM

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.

Vea el artículo principal de la semana pasada: Estado actual de los biosimilares de anticuerpos monoclonales aprobados en América Latina

!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. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 1]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion seeks approval for bevacizumab biosimilar in Europe, US and Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 1]. Available from: www.gabionline.net/biosimilars/news/celltrion-seeks-approval-for-bevacizumab-biosimilar-in-europe-us-and-korea

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 © 2022 Pro Pharma Communications International. All Rights Reserved.

Source: Celltrion, EMA

comment icon Comments (0)
Post your comment
Related content
La FDA aprueba el biosimilar pegfilgrastim Stimufend
Approved-V13G05
Biosimilares/Novedades Posted 07/10/2022
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