EMA recommends approval of two adalimumab biosimilars

Biosimilars/News | Posted 01/10/2021 post-comment0 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.

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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 

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Source: Alvotech, EMA

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