EMA accepts application for high concentration adalimumab biosimilar

Biosimilars/News | Posted 08/07/2022 post-comment0 Post your comment

Sandoz, the generics division of Novartis, announced on 17 June 2022 that the European Medicines Agency (EMA) has accepted the application for its high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017).

picture 146

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis. 

Sandoz is seeking approval for Hyrimoz HCF in the same indications as the reference biological, AbbVie’s Humira (adalimumab).

The application is supported by a comprehensive submission package, which includes a phase I pharmacokinetics bridging study comparing Hyrimoz 50 mg/mL and Hyrimoz HCF (100 mg/mL). According to Sandoz, this study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the 50 mg/mL Hyrimoz formulation and Hyrimoz HCF (100 mg/mL).

Sandoz says that, upon approval, Hyrimoz HCF citrate-free would offer reduced injection volume and potentially decrease the number of injections required for patients who need 80 mg dosing. Hyrimoz HCF will have the same auto injector as the 50 mg/mL Hyrimoz formulation, a fact that Sandoz claims will give ‘an enhanced yet familiar patient experience’.

Sandoz already has 10 biosimilars approved in the European Union [1] and four in the US [2]. EMA has already approved two other high-concentration adalimumab biosimilars. Hukyndra and Libmyris are both high-concentration (100 mg/mL) biosimilars of Alvotech’s proposed biosimilar AVT02 [3].

Related article
Biosimilars of adalimumab

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 this week’s headline article: Directrices revisadas de la OMS para los biosimilares: antecedentes científicos

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 esta semana: Directrices revisadas de la OMS para los biosimilares: antecedentes científicos

!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 8]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 8]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of two adalimumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 8]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-two-adalimumab-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 © 2022 Pro Pharma Communications International. All Rights Reserved.

Source: Sandoz

comment icon Comments (0)
Post your comment
Related content
EC approval of first ustekinumab biosimilar Uzpruvo
IBD 1
Biosimilars/News Posted 16/01/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010