EMA recommends approval of bevacizumab biosimilar Equidacent

Biosimilares/Novedades | Posted 28/08/2020 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it had recommended granting of marketing authorization for the bevacizumab biosimilar Equidacent, which is produced by Centus Biotherapeutics, a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics

Bevacizumab 2 V14f01

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (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.

EMA adopted a positive opinion for the marketing authorization of Equidacent for the following indications: 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. The drug will be available as a 25 mg/mL concentrate for solution for infusion.

The recommendation was based on data from analytical testing, preclinical and clinical studies demonstrating biosimilarity to the reference product, Avastin. This included a phase III clinical trial which showed no clinically meaningful differences in terms of safety, efficacy or immunogenicity to Avastin in patients with non-small cell lung cancer.

Commenting on the news, Centus President and Product Development Team Lead Dr Hiroshi Ohashi said: ‘We are very happy receiving a positive CHMP [Committee for Medicinal Products for Human Use] opinion toward approval of Equidacent, our bevacizumab biosimilar. We will continue with every effort to bring Equidacent to patients and healthcare professionals’.

The European Commission is expected to give final approval to Equidacent in September 2020, allowing Centus to begin selling the product in the European Union, as well as the UK and European Economic Area Member States.

EMA recently recommended granting marketing authorization for a further bevacizumab biosimilar, Aybintio, which is produced by Korea-based Samsung Bioepis [1].

Related articles
Genentech and Amgen settle biosimilar disputes

Biosimilars applications under review by EMA – July 2020

China approves bevacizumab copy biological Byvasda

1. GaBI Online - Generics and Biosimilars Initiative. EMA approves bevacizumab and teriparatide biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Aug 28]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-bevacizumab-and-teriparatide-biosimilars

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 © 2020 Pro Pharma Communications International. All Rights Reserved.

Source: Centus Biotherapeutics, EMA

comment icon Comments (0)
Post your comment
Related content
Canadá aprueba tres biosimilares más en 2022
Health Canada V13I20
Biosimilares/Novedades Posted 28/05/2024
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