The European Commission (EC) granted marketing authorization for eight biosimilars: Biocon’s Yesintek,Celltrion’s Avtozma, Eydenzelt, Osenvelt and Stoboclo; Samsung Bioepis’ Obodence and Xbryk, and CuraTeQ Biologics’ Zefylti in February 2025.
The eight biosimilars approved by the EC include one aflibercept, four denosumab, one each of aflibercept, filgrastim, tocilizumab, and ustekinumab, see Table 1.
Out of the eight biosimilars approved in the EC, four have also received approval in the US. These include Avtozma (tocilizumab-anoh) approved on 24 January 2025 [1]; Ospomyv and Xbryk (denosumab-dssb) approved on 13 February 2025 [2]; Yesintek (ustekinumab-kfce) approved on 29 November 2024 [3].
Notably, Ospomyv and Xbryk (denosumab-dssb), was granted the provisional 'interchangeable' designation, marking them as the first interchangeable biosimilars to Amgen’s Prolia and Xgeva (denosumab). Europe’s Obodence was approved under the name of Ospomyv in the US.
| Table 1: EC-approved biosimilars in February 2025
|
| Product name
|
Active substance
|
Authorization date
|
Manufacturer/ Company name
|
| Avtozma
|
tocilizumab
|
14 Feb 2025
|
Celltrion
|
| Eydenzelt
|
aflibercept
|
12 Feb 2025
|
Celltrion
|
| Obodence
|
denosumab
|
12 Feb 2025
|
Samsung Bioepis
|
| Osenvelt
|
denosumab
|
14 Feb 2025
|
Celltrion
|
| Stoboclo
|
denosumab
|
14 Feb 2025
|
Celltrion
|
| Xbryk
|
denosumab
|
12 Feb 2025
|
Samsung Bioepis
|
| Yesintek
|
ustekinumab
|
14 Feb 2025
|
Biocon
|
| Zefylti
|
filgrastim
|
12 Feb 2025
|
CuraTeQ Biologics (Aurobindo)
|
| *Data updated 10 April 2025
|
As of 31 March 2025, six biosimilars are still pending for EC approval after receiving positive opinions from the CHMP (Committee for Medicinal Products for Human Use). These include Pavblu and Skojoy (aflibercept) and Dyrupeg (pegfilgrastim), which were granted positive opinions on 30 January 2025 [4], as well as Jubereq and Osvyrti (denosumab), and Qoyvolma (ustekinumab), which received positive opinions on 27 March 2025 [5]. The final step for these biosimilars to enter the European market is the EC formal approval.
Related article
Biosimilars approved in Europe
References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves tocilizumab biosimilar Avtozma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 22]. Available from: www.gabionline.net/biosimilars/news/fda-approves-tocilizumab-biosimilar-avtozma
2. GaBI Online - Generics and Biosimilars Initiative. Insulin aspart and denosumab biosimilars approved in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 22]. Available from: www.gabionline.net/biosimilars/news/insulin-aspart-and-denosumab-biosimilars-approved-in-us
3. GaBI Online - Generics and Biosimilars Initiative. Ustekinumab biosimilars Yesintek, Steqeyma, and Otulfi approved by FDA, EMA and Health Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 22]. Available from: www.gabionline.net/biosimilars/news/ustekinumab-biosimilars-yesintek-steqeyma-and-otulfi-approved-by-fda-ema-and-health-canada
4. GaBI Online - Generics and Biosimilars Initiative. January 2025 biosimilar approvals in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 22]. Available from: www.gabionline.net/biosimilars/news/january-2025-biosimilar-approvals-in-europe
5. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for three biosimilars: Jubereq, Osvyrti, and Qoyvolma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 22]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-three-biosimilars-jubereq-osvyrti-and-qoyvolma
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