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.
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.
Continue at: https://www.gabionline.net/biosimilars/news/ec-approves-eight-biosimilars-six-more-await-final-authorization
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