EMA recommends approval of two adalimumab biosimilars

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

EMA recommends approval of two adalimumab biosimilars

Biosimilars/News | Posted 01/10/2021 0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 17 September 2021 that it had recommended granting marketing authorization for the adalimumab biosimilars Hukyndra and Libmyris.

The proposed biosimilars are a result of a collaboration between Icelandic biosimilar manufacturer Alvotech and German generics giant Stada Arzneimittel (Stada). Alvotech signed a strategic collaboration with Stada back in 2019 for the commercialization of seven biosimilar candidates [1].

Hukyndra and Libmyris are both high-concentration (100 mg/mL) biosimilars of Alvotech’s proposed biosimilar AVT02.

Alvotech announced in June 2021 the completion of its switching study for AVT02 [2]. The company aims to use these results to support the approval of AVT02 as an interchangeable biosimilar in the US, to be interchangeable with high concentration (100 mg/mL) forms of the originator product Humira (adalimumab).

The CHMP recommended at its meeting held on 13–16 September 2021 that the two adalimumab biosimilars receive a positive opinion for the treatment of inflammatory autoimmune disorders, such as arthritis psoriasis, inflammatory bowel disease or uveitis.

These recommendations bring the number of adalimumab biosimilars to be approved in Europe up to 12, although these are the first to be approved at the high concentration (100 mg/mL) [3].

The CHMP’s positive opinion for the adalimumab biosimilars will now be referred to the European Commission, which grants marketing authorizations for medicines in the European Union. If approved, a centralized marketing authorization for AVT02 would extend to all EU Member States, as well as countries in the European Economic Area (EEA), Iceland, Liechtenstein and Norway.

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: Política de sustitución de biosimilares de Canadá: efectos sobre la competencia y seguridad del paciente 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: Política de sustitución de biosimilares de Canadá: efectos sobre la competencia y seguridad del paciente 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. Alvotech signs agreements with Stada and Yas Holding [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 1]. Available from: www.gabionline.net/pharma-news/Alvotech-signs-agreements-with-Stada-and-Yas-Holding
2. GaBI Online - Generics and Biosimilars Initiative. Alvotech and Celltrion proceed with adalimumab and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 1]. Available from: www.gabionline.net/biosimilars/research/alvotech-and-celltrion-proceed-with-adalimumab-and-rituximab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 1]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe

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.

Source: Alvotech, EMA