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 106 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, see Table 1.

On 21 March 2024, denosumab from Sandoz received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP) for its biosimilar denosumab under two brand names – Jubbonti and Wyost.

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].

Seventeen biosimilar approvals have been withdrawn after approval, see Table 2:
• four for adalimumab biosimilars: Boehringer Ingelheim’s Cyltezo in January 2019, Amgen’s Solymbic in March 2019, Fresenius Kabi’s Kromeya in December 2019 and Sandoz’s Halimatoz in January 2021
• two for bevacizumab biosimilars: Equidacent from Centus Biotherapeutics in November 2021 and Mylan’s (now Viatris) Lextemy in December 2021
• one for an enoxaparin sodium biosimilar: Pharmathen’s Thorinane in October 2019
• two for filgrastim biosimilars: Filgrastim ratiopharm in April 2011 and CT Arzneimittel’s Biograstim in December 2016
• one for an human insulin biosimilar: Biocon’s Inpremzia in April 2023
• one for an insulin glargine biosimilar: Merck’s Lusduna in October 2018
• one for a pegfilgrastim biosimilar: ERA Consulting’s (Coherus Biosciences) Udenyca in February 2021
• two for rituximab biosimilars: Celltrion’s Rituzena in April 2019 and Celltrion’s Ritemvia in August 2021
• two for somatropin biosimilars: Biopartner’s Valtropin in May 2012 and Somatropin Biopartners in November 2017
• one for a teriparatide biosimilar: Qutavina from EuroGenerics Holdings in January 2018

Four biosimilar were withdrawn before approval: Reliance GeneMedix’s epoetin alfa biosimilar, Epostim; Mabion’s rituximab biosimilar, and the pegfilgrastim biosimilars of Stada’s Cavoley and Gedeon Richter’s Efgratin, see Table 2.

Two biosimilar applications were refused by the agency: an interferon alfa-2a biosimilar, Alpheon, from Biopartners; and a human insulin biosimilar, Solumarv, from Marvel Lifesciences, see Table 2.

By end of December 2023, there is a total of 17 biosimilars withdrawn after approval, four withdrawn before approval, and two refused, in the classes of 1) human growth hormone; 2) granulocyte colony-stimulating factor; 3) erythropoiesis stimulating agent; 4) insulin; 5) parathyroid hormone; and 6) monoclonal antibody.

This leaves a total of 89 biosimilars approved for use in Europe.

The positive opinion reached by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on 26 July 2014 for the insulin glargine biosimilar Abasaglar (previously Abasria) came as a relief to diabetes sufferers in Europe, after the disappointing withdrawal of the applications for three biosimilar insulin products by Marvel LifeSciences in November 2012 [5]. The positive opinion reached by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on 27 June 2013 for the infliximab biosimilars Inflectra and Remsima was a landmark decision, proving that the biosimilar concept can be successfully applied to such complex molecules as monoclonal antibodies.

Related articles
Remsima approved in Colombia

EMA approves first monoclonal antibody biosimilar

Biosimilar monoclonal antibody approved in Korea

References
1.  GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
2.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Reports/Biosimilars-use-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Dr Reddy's launches bevacizumab biosimilar Versavo in the UK [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 16]. Available from: www.gabionline.net/biosimilars/news/dr-reddy-s-launches-bevacizumab-biosimilar-versavo-in-the-uk
4. GaBI Online - Generics and Biosimilars Initiative. Formycon launches biosimilar ranibizumab Ravegza in Saudi, Gedeon Richter invests [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 16]. Available from: www.gabionline.net/pharma-news/formycon-launches-biosimilar-ranibizumab-ravegza-in-saudi-gedeon-richter-invests 
5. GaBI Online - Generics and Biosimilars Initiative. Marvel withdraws biosimilar insulin applications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Biosimilars/News/Marvel-withdraws-biosimilar-insulin-applications

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