TOP 20 Companies with more Biosimilars approved in Europe

admin April 28, 2025No Comments

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.

EMA first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006, and since then EMA has developed many general and specific guidelines for biosimilars [1].

Omnitrope (somatropin) was the first product approved in the EU as a biosimilar in 2006 [2]. To date, EMA has recommended the approval of 132 biosimilars within the product classes of: 1) human growth hormone; 2) granulocyte colony-stimulating factor; 3) erythropoiesis stimulating agent; 4) insulin; 5) follicle-stimulating hormone (FSH); 6) parathyroid hormone; 7) tumour necrosis factor (TNF)-inhibitor; 8) vascular endothelial growth factor (VEGF) inhibitor, and 9) monoclonal antibody for use in the EU:

In the first quarter of 2025, the EMA’s Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for the six biosimilars listed below,

Amgen’s aflibercept biosimilar Pavblu and Skojoy
CuraTeQ Biologics’ pegfilgrastim biosimilar Dyrupeg
Accord Healthcare’s denosumab biosimilar Jubereq and Osvyrti
Celltrion’s ustekinumab biosimilar Qoyvolma

Several of the biosimilars are approved under two brand names, including:

Accord Healthcare’s Jubereq and Osvyrti (denosumab)
Amgen’s Pavblu and Skojoy (aflibercept)
Samsung Bioepis’ Obodence and Xbryk (denosumab)
Sandoz’s Jubbonti and Wyost (denosumab)
Celltrion’s Osenvelt and Stoboclo (denosumab)

On 19 March 2024, Dr Reddy’s Laboratories announced that it would be launching Versavo, a bevacizumab biosimilar, in the UK [3]. However, Versavo has not yet been submitted to the EMA for approval. Also in March 2024, Formycon’s biosimilar ranibizumab, Ravegza (FYB201), received marketing authorization from the Saudi Food & Drug Authority. This product is approved in Europe under the brand name Ranivisio [4].