The European Commission (EC) granted marketing authorization for seven biosimilars: Sandoz’s Afqlir, Formycon’s Ahzantive/Baiama, Accord Healthcare’s Absimky and Imuldosa, Samsung Bioepis’ Opuviz, Midas Pharma’s Ranibizumab Midas, and Prestige Biopharma’s Tuznue during September 2024 to January 2025.
By the end of January 2025, the EC has approved a total of eight biosimilars, see Table 1. The approved biosimilars include three aflibercept products, two ustekinumab products, and one product each of ranibizumab, rituximab, and trastuzumab.
| Table 1: EC-approved biosimilars by January 2025
|
| Product name
|
Active substance
|
Authorization date
|
Manufacturer/ Company name
|
| Afqlir
|
aflibercept
|
13 Nov 2024
|
Sandoz
|
| Ahzantive/Baiama
|
aflibercept
|
13 Jan 2025
|
Formycon AG
|
| Absimky
|
ustekinumab
|
12 Dec 2024
|
Accord Healthcare
|
| Imuldosa
|
ustekinumab
|
12 Dec 2024
|
Accord Healthcare
|
| Ituxredi
|
rituximab
|
19 Sep 2024
|
Reddy Holding
|
| Opuviz
|
aflibercept
|
13 Nov 2024
|
Samsung Bioepis
|
| Ranibizumab Midas
|
ranibizumab
|
19 Sep 2024
|
Midas Pharma GmbH
|
| Tuznue
|
trastuzumab
|
19 Sep 2024
|
Prestige Biopharma
|
| *Data updated 4 February 2025
|
Out of the eight biosimilars approved in the EC, three have also received approval in the United States. These include Ahzantive (aflibercept-mrbb), approved on 28 June 2024 [1]; Imuldosa (ustekinumab-srlf), approved on 10 October 2024 [2]; and Opuviz (aflibercept-yszy), approved on 20 May 2024 [3]. Notably, Opuviz, along with Yesafili (aflibercept-jbvf), was granted the 'interchangeable' designation, marking them as the first interchangeable biosimilars to Regeneron and Bayer's Eylea (aflibercept). This designation further enhances their regulatory standing.
As of the end of 2024, eight biosimilars are still pending for EC approval after receiving positive opinions from the CHMP (Committee for Medicinal Products for Human Use). These include Xbryk and Obodence (denosumab), which were granted positive opinions on 14 November 2024, as well as Yesintek (ustekinumab), Zefylti (filgrastim), Avtozma (tocilizumab), Eydenzelt (aflibercept)/CT-P42, Osenvelt (denosumab), and Stoboclo (denosumab), all of which received positive opinions on 12 December 2024. The final step for these biosimilars to enter the European market is the EC formal approval.
Related article
Biosimilars approved in Europe
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves third aflibercept biosimilar Ahzantive [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 18]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-aflibercept-biosimilar-ahzantive
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves fifth ustekinumab biosimilar Imuldosa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 18]. Available from: www.gabionline.net/biosimilars/news/fda-approves-fifth-ustekinumab-biosimilar-imuldosa
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable aflibercept biosimilars to treat macular degeneration [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 18]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-aflibercept-biosimilars-to-treat-macular-degeneration
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