The European Commission (EC) granted marketing authorization for three biosimilars: Amgen’s Pavblu,CuraTeQ Biologics’s Dyrupeg, and Celltrion’s Qoyvolma, between March and June 2025.
CuraTeQ Biologics is a wholly owned step-down subsidiary of Aurobindo Pharma. The CHMP approved no biosimilars in April 2025.
The three biosimilars approved by the EC include one each of aflibercept, pegfilgrastim, and ustekinumab, see Table 1.
| Table 1: EC-approved biosimilars by early June 2025
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| Product name
|
Active substance
|
Authorization date
|
Manufacturer/ Company name
|
| Pavblu
|
aflibercept
|
10 Apr 2025
|
Amgen
|
| Dyrupeg
|
pegfilgrastim
|
28 Mar 2025
|
CuraTeQ Biologics
|
| Qoyvolma
|
ustekinumab
|
2 Jun 2025
|
Celltrion
|
| *Data updated 11 June 2025
|
Out of the three biosimilars approved in the EC, only Pavblu has received approval in the US. Pavblu (aflibercept-ayyh) was approved on 23 August 2024 [1].
However, Skojoy (an aflibercept biosimilar) which received a CHMP (Committee for Medicinal Products for Human Use) positive opinion 30 Jan 2025, had its duplicate Marketing Authorisation Application (MAA) withdrawn by Amgen on 4 March 2025. This decision was due to a change in the company’s marketing strategy for the duplicate MAA and is unrelated to the product’s quality or safety.
Other biosimilars MAAs withdrawn before approval includes Ascend’s Teriparatide Ascend on 6 May 2025 and Accord’s Pelgraz Paediatric (pegfilgrastim) on 20 February 2025.
As of 20 June 2025, 14 biosimilars are still pending for EC approval after receiving positive opinions from the CHMP. These include 13 denosumab biosimilars - Osvyrti, Denosumab BBL, Izamby, Junod, Zadenvi, Conexxence, and Rolcya (referencing Prolia), as well as Jubereq, Denbrayce, Enwylma, Vevzuo, Yaxwer, and Bomyntra (referencing Xgeva) – along with one trastuzumab biosimilar, Dazublys, which received positive opinions on 25 April and 23 May 2025 [2, 3]. The final step for these biosimilars to enter the European market is the EC formal approval.
Related articles
EC approves eight biosimilars, six more await final authorization
EC approves eight biosimilars, eight more await final authorization
Biosimilars approved in Europe
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves aflibercept biosimilars Enzeevu and Pavblu [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 20]. Available from: www.gabionline.net/biosimilars/news/fda-approves-aflibercept-biosimilars-enzeevu-and-pavblu
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for three denosumab biosimilars: Bomyntra, Conexxence, and Rolcya [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 20]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-three-denosumab-biosimilars-bomyntra-conexxence-and-rolcya
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends nine biosimilars for approval including trastuzumab and denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 20]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-nine-biosimilars-for-approval-including-trastuzumab-and-denosumab
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