EMA recommends approval of adalimumab and insulin aspart biosimilars

Biosimilares/Novedades | Posted 22/01/2021 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting marketing authorization for the adalimumab biosimilar Yuflyma and for the insulin aspart biosimilar Kixelle.

11453696_l

During the CHMP’s meeting of 7‒10 December 2020, the committee recommended that Yuflyma receive a positive opinion for the treatment of certain inflammatory and autoimmune disorders.

Yuflyma (CT-P17) is produced by Korea-based biotechnology company Celltrion Healthcare. The company submitted its application to EMA in March 2020 and included clinical data on all indications for the reference product Humira (adalimumab), including rheumatoid arthritis, ulcerative colitis and psoriasis [1].

This is not the first adalimumab biosimilar to be approved in Europe. The European Commission (EC) has already approved 10 other adalimumab biosimilars [2]. However, if approved, Yuflyma would be the first adalimumab biosimilar with a high concentration (100 mg/mL) and citrate-free formulation, which is expected to produce less pain for patients during administration.

The CHMP has recommended that Kixelle (insulin aspart) be approved for the treatment of diabetes mellitus. Kixelle is produced by US-based drugmaker Mylan and Indian biologicals specialist Biocon.

Kixelle, if approved, will be the second insulin aspart biosimilars to be approved in Europe. Insulin aspart Sanofi gained European approval in April 2020 [3].

The positive opinions by EMA’s CHMP will now be reviewed by the EC, which is expected to give final marketing approval within the next three months.

Related article
Biosimilars of adalimumab

LATIN AMERICAN FORUM – Coming soon!

To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

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

 

LATIN AMERICAN FORUM – Próximamente!

Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

References
1. GaBI Online - Generics and Biosimilars Initiative. Celltrion files application with EMA for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-files-application-with-EMA-for-adalimumab-biosimilar 
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for Sanofi’s insulin aspart biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-Sanofi-s-insulin-aspart-biosimilar

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 © 2021 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