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Last update: 20 June 2025
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 144 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.
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, also see Table 1:
Several of the biosimilars are approved under two brand names, including:
However, Skojoy had its duplicate Marketing Authorisation Application withdrawn by Amgen on 4 March 2025.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.
In April 2025, the CHMP granted a positive opinion for nine biosimilars including one trastuzumab biosimilar and eight denosumab biosimilars, as listed in Table 1, they are:
In May 2025, the CHMP granted a positive opinion for three denosumab biosimilars (Conexxence, Rolcya, and Bomyntra, bringing the total number of approved denosumab biosimilars in Europe to 19.
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].
| Table 1: EMA approved biosimilars* |
| Product name | Active substance | Therapeutic area | Authorization date |
Manufacturer/ Company name |
| Abasaglar (previously Abasria) | insulin glargine | Diabetes mellitus | 9 Sep 2014 | Eli Lilly/Boehringer Ingelheim |
| Abevmy | bevacizumab |
Breast cancer Carcinoma of the cervix Colon cancer Fallopian tube cancer Non-small-cell lung carcinoma Ovarian cancer Peritoneal cancer Renal cell cancer |
21 Apr 2021 | Mylan (now Viatris) |
| Abseamed | epoetin alfa |
Anaemia Cancer Chronic kidney failure |
27 Aug 2007 | Medice Arzneimittel Pütter |
| Absimky | ustekinumab |
Crohn’s disease Paediatric psoriatic arthritis Plaque psoriasis Psoriatic arthritis |
12 Dec 2024 | Accord Healthcare |
| Accofil | filgrastim | Neutropenia | 17 Sep 2014 | Accord Healthcare |
| Afqlir | aflibercept |
Diabetic macular oedema (DME) Macular oedema following retinal vein occlusion (branch RVO or central RVO) Myopic choroidal neovascularisation (myopic CNV) Neovascular (wet) age-related macular degeneration (AMD) |
13 Nov 2024 | Sandoz |
|
Ahzantive/ Baiama |
aflibercept |
Diabetic macular oedema (DME) Myopic choroidal neovascularisation (myopic CNV) Neovascular (wet) age-related macular degeneration (AMD) Visual impairment due to macular oedema secondary to retinal vein occlusion |
13 Jan 2025 | Formycon AG |
| Alymsys | bevacizumab |
Breast cancer Carcinoma of the cervix Colon cancer Fallopian tube cancer Non-small-cell lung carcinoma Ovarian cancer Peritoneal cancer Renal cell cancer |
26 Mar 2021 | mAbxience Research |
| Amgevita | adalimumab |
Ankylosing spondylitis Crohn’s disease Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis |
21 Mar 2017 | Amgen |
| Amsparity | adalimumab |
Ankylosing spondylitis Hidradenitis Suppurativa Crohn’s disease Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis Uvetis |
13 Feb 2020 | Pfizer |
| Aybintio | bevacizumab |
Breast neoplasms Colorectal neoplasms Fallopian tube neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Peritoneal neoplasms Renal cell carcinoma Uterine cervical neoplasms |
19 Aug 2020 | Samsung Bioepis |
| Avtozma | tocilizumab |
COVID-19 Cytokine release syndrome (CRS) Giant cell arteritis (GCA) Polyarticular juvenile idiopathic arthritis (pJIA) Rheumatoid arthritis Systemic juvenile idiopathic arthritis (sJIA) |
14 Feb 2025 | Celltrion |
| Avzivi | bevacizumab |
Carcinoma, non-small-cell lung Carcinoma, renal cell Colorectal neoplasms Fallopian tube neoplasms Ovarian neoplasms Peritoneal neoplasms Uterine cervical neoplasms |
26 Jul 2024 | Bio-Thera Solutions, marketed by Sandoz |
| Bekemv | eculizumab |
Atypical haemolytic uraemic syndrome (aHUS) Paroxysmal nocturnal haemoglobinuria (PNH) |
24 Feb 2023 | Amgen |
| Bemfola | follitropin alfa | Anovulation (IVF) | 26 Mar 2014 | Finox Biotech |
| Benepali | etanercept |
Axial spondyloarthritis Psoriatic arthritis Plaque psoriasis Rheumatoid arthritis |
13 Jan 2016 | Samsung Bioepis |
| Binocrit | epoetin alfa |
Anaemia Chronic kidney failure |
28 Aug 2007 | Sandoz |
| Blitzima | rituximab |
Non-Hodgkin lymphoma Chronic B-cell lymphocytic leukaemia |
13 Jul 2017 | Celltrion |
| Bomyntra | denosumab |
Prevention of skeletal-related events in adult with advanced malignancies involving bone Giant cell tumour of bone |
CHMP positive opinion 23 May 2025 | Fresenius Kabi |
| Byooviz | ranibizumab |
Degenerative myopia Diabetic retinopathy Macular edema Wet macular degeneration |
18 Aug 2021 | Samsung Bioepis |
| Cegfila (previously Pegfilgrastim Mundipharma) | pegfilgrastim | Neutropenia | 19 Dec 2019 | Mundipharma Biologics |
| Conexxence | denosumab | Osteoporosis | CHMP positive opinion 23 May 2025 | Fresenius Kabi |
| Dazublys | trastuzumab | metastatic and early breast cancer | CHMP positive opinion 25 Apr 2025 | CuraTeQ Biologics |
| Denbrayce | denosumab |
Giant cell tumour of bone Prevention of skeletal related events |
CHMP positive opinion 25 Apr 2025 | mAbxience Research |
| Denosumab BBL | denosumab |
Bone loss Osteoporosis |
CHMP positive opinion 25 Apr 2025 | Biosimilar Collaborations Ireland Ltd |
| Dyrupeg | pegfilgrastim | Neutropenia | 28 Mar 2025 | CuraTeQ Biologics |
| Eksunbi | ustekinumab |
Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis Ulcerative colitis |
12 Sep 2024 | Samsung Bioepis NL BV |
| Enoxaparin BECAT | enoxaparin sodium | Venous thromboembolism | 24 Mar 2017 | Laboratorios ROVI |
| Enwylma | denosumab |
Giant cell tumour of bone Prevention of skeletal related events |
CHMP positive opinion 25 Apr 2025 | Zentiva |
| Epoetin alfa Hexal | epoetin alfa |
Anaemia Cancer Chronic kidney failure |
27 Aug 2007 | Hexal |
| Epysqli | eculizumab |
Atypical Hemolytic Uremic Syndrome (aHUS) Paroxysmal nocturnal hemoglobinuria: adult and children |
26 May 2023 22 Mar 2024 (for aHUS) |
Samsung Bioepis |
| Erelzi | etanercept |
Ankylosing spondylitis Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis |
23 Jun 2017 | Sandoz |
| Eydenzelt | aflibercept |
Diabetic macular oedema (DME) Myopic choroidal neovascularisation (myopic CNV) Neovascular (wet) age-related macular degeneration (AMD) Visual impairment due to macular oedema secondary to retinal vein occlusion |
12 Feb 2025 | Celltrion |
| Filgrastim Hexal | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
6 Feb 2009 | Hexal |
| Flixabi | infliximab |
Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
26 May 2016 | Samsung Bioepis |
| Fulphila | pegfilgrastim | Neutropenia | 20 Nov 2018 | Mylan (now Viatris) |
| Fymskina | ustekinumab |
Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis Ulcerative colitis |
25 Sep 2024 | Formycon AG |
| Grastofil | filgrastim | Neutropenia | 17 Oct 2013 | Apotex |
| Grasustek | pegfilgrastim | Neutropenia | 20 Jun 2019 | Juta Pharma (USV) |
| Hefiya | adalimumab |
Ankylosing spondylitis Hidradenitis suppurativa Juvenile rheumatoid arthritis Psoriasis Uveitis |
26 Jul 2018 | Sandoz |
| Herzuma | trastuzumab |
Early breast cancer Metastatic breast cancer Metastatic gastric cancer |
8 Feb 2018 | Celltrion Healthcare |
| Herwenda | trastuzumab |
Early breast cancer Metastatic breast cancer Metastatic gastric cancer |
15 Nov 2023 | Sandoz GmbH |
| Hukyndra | adalimumab |
Ankylosing spondylitis Crohn’s Disease Hidradenitis suppurativa Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative Colitis Uveitis |
15 Nov 2021 | Alvotech/Stada Artnimettel |
| Hulio | adalimumab |
Ankylosing spondylitis Crohn’s Disease Hidradenitis suppurativa Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative Colitis Uveitis |
17 Sep 2018 | Mylan/Fujifilm Kyowa Kirin Biologics |
| Hyrimoz | adalimumab |
Ankylosing spondylitis Crohn’s Disease Hidradenitis suppurativa Juvenile rheumatoid arthritis Papulosquamous skin disease Psoriatic arthritis Rheumatoid arthritis Ulcerative Colitis Uveitis |
26 Jul 2018 | Sandoz |
| Idacio | adalimumab |
Ankylosing spondylitis Arthritis Crohn’s Disease Hidradenitis suppurativa Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis Uveitis |
2 Apr 2019 | Fresenius Kabi |
| Imraldi | adalimumab |
Ankylosing spondylitis Arthritis Crohn’s Disease Hidradenitis suppurativa Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis Uveitis |
24 Aug 2017 | Samsung Bioepis |
| Imuldosa | ustekinumab |
Crohn’s disease paediatric psoriatic arthritis plaque psoriasis psoriatic arthritis ulcerative colitis |
12 Dec 2024 | Accord Healthcare |
| Inflectra | infliximab |
Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
10 Sep 2013 | Hospira (Pfizer) |
| Inhixa | enoxaparin sodium | Venous thromboembolism | 15 Sep 2016 | Techdow Europe |
| Insulin aspart Sanofi | insulin aspart | Diabetes mellitus | 25 Jun 2020 | Sanofi-Aventis |
| Insulin lispro Sanofi | insulin lispro | Diabetes mellitus | 18 Jul 2017 | Sanofi-Aventis |
| Ituxredi | rituximab |
Chronic lymphocytic leukaemia Granulomatosis with polyangiitis and microscopic polyangiitis Non-Hodgkin’s lymphoma Pemphigus vulgar Rheumatoid arthritis |
19 Sep 2024 | Reddy Holding |
| Izamby | denosumab |
Bone loss Osteoporosis |
CHMP positive opinion 25 Apr 2025 | mAbxience Research |
| Jubereq, see also Osvyrti | denosumab |
Bone tissue neoplasms Giant cell tumour of bone |
CHMP positive opinion 27 Mar 2025 | Accord Healthcare |
| Jubbonti | denosumab |
Bone resorption Osteoporosis Postmenopausal osteoporosis |
16 May 2024 | Sandoz GmbH |
| Junod | denosumab |
Bone loss Osteoporosis |
CHMP positive opinion 25 Apr 2025 | Gedeon Richter |
| Kanjinti | trastuzumab |
Early breast cancer Metastatic breast cancer Metastatic gastric cancer |
16 May 2018 | Amgen/Allergan |
| Kirsty (previously Kixelle) | insulin aspart | Diabetes mellitus | 5 February 2021 | Biocon/Viatris (formerly Mylan) |
| Libmyris | adalimumab |
Ankylosing spondylitis Crohn’s Disease Hidradenitis suppurativa Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative Colitis Uveitis |
12 Nov 2021 | Alvotech/Stada Artnimettel |
| Livogiva | teriparatide | Osteoporosis | 27 Aug 2020 | Theramex Ireland |
| Movymia | teriparatide | Osteoporosis | 11 Jan 2017 | Stada Arzneimittel |
| Mvasi | bevacizumab |
Breast neoplasms Fallopian tube neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Peritoneal neoplasms Renal cell carcinoma |
15 Jan 2018 | Amgen |
| Nepexto | etanercept |
Ankylosing spondylitis Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Spondylarthropathies |
25 May 2020 | Mylan (now Viatris) |
| Nivestim | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
7 Jun 2010 | Hospira (Pfizer) |
| Nyvepria | pegfilgrastim | Neutropenia | 18 Nov 2020 | Pfizer |
| Obodence | denosumab |
Bone resorption Osteoporosis Postmenopausal osteoporosis |
12 Feb 2025 | Samsung Bioepis |
| Ogivri | trastuzumab |
Early breast cancer Metastatic breast cancer Metastatic gastric cancer |
12 Dec 2018 | Biocon/Mylan |
| Omlyclo | omalizumab |
Asthma Urticaria |
23 May 2024 | Celltrion Healthcare |
| Omnitrope | somatropin |
Pituitary dwarfism Prader-Willi syndrome Turner syndrome |
12 Apr 2006 | Sandoz |
| Onbevzi | bevacizumab |
Breast neoplasms Colorectal neoplasms Fallopian tube neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Peritoneal neoplasms Renal cell carcinoma Uterine Cervical Neoplasms |
11 Jan 2021 | Samsung Bioepis |
| Ontruzant | trastuzumab |
Early breast cancer Metastatic breast cancer Metastatic gastric cancer |
15 Nov 2017 | Samsung Bioepis |
| Opuviz | aflibercept |
Diabetic macular oedema (DME) Macular oedema following retinal vein occlusion (branch RVO or central RVO) Myopic choroidal neovascularisation (myopic CNV) Neovascular (wet) age-related macular degeneration (AMD) |
13 Nov 2024 | Samsung Bioepis |
| Osenvelt | denosumab |
Giant cell tumor of bone Neoplasms, Bone tissue |
14 Feb 2025 | Celltrion |
| Osvyrti, see also Jubereq | denosumab |
Bone resorption Osteoporosis Postmenopausal osteoporosis |
CHMP positive opinion 27 Mar 2025 | Accord Healthcare |
| Otulfi | ustekinumab |
Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis Ulcerative colitis |
25 Sep 2024 | Fresenius Kabi |
| Oyavas | bevacizumab |
Breast cancer Carcinoma of the cervix Colon cancer Fallopian tube cancer Non-small-cell lung carcinoma Ovarian cancer Peritoneal cancer Renal cell cancer |
26 Mar 2021 | Stada Arzneimittel |
| Ovaleap | follitropin alfa | Anovulation (IVF) | 27 Sep 2013 | Teva Pharma |
| Pavblu | aflibercept |
Choroidal Neovascularization Diabetes Complications Macular Edema Retinal Vein Occlusion Wet Macular Degeneration |
10 April 2025 | Amgen |
| Pelgraz | pegfilgrastim | Neutropenia | 21 Sep 2018 | Accord Healthcare |
| Pelmeg | pegfilgrastim | Neutropenia | 20 Nov 2018 | Cinfa Biotech/Mundipharma |
| Pyzchiva | ustekinumab |
Crohn’s disease Paediatric plaque psoriasis Psoriatic arthritis Ulcerative colitis |
22 Apr 2024 | Samsung Bioepis |
| Qoyvolma | ustekinumab |
Crohn’s disease Paediatric plaque psoriasis Psoriatic arthritis Ulcerative colitis |
2 Jun 2025 | Celltrion |
| Ranibizumab Midas | ranibizumab |
Neovascular (wet) age-related macular degeneration (AMD) Diabetic macular oedema (DME) Proliferative diabetic retinopathy (PDR) Branch RVO or central RVO Choroidal neovascularisation (CNV) |
19 Sep 2024 | Midas Pharma GmbH |
| Ratiograstim | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
15 Sep 2008 | Ratiopharm |
| Remsima | infliximab |
Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
10 Sep 2013 | Celltrion |
| Ranibizumab Midas | ranibizumab |
Neovascular (wet) age-related macular degeneration (AMD) Visual impairment due to diabetic macular oedema (DME) Proliferative diabetic retinopathy (PDR) Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) Visual impairment due to choroidal neovascularisation (CNV) |
CHMP positive opinion 25 July 2024 | Midas Pharma GmbH |
| Ranivisio | ranibizumab |
Diabetes complications Diabetic retinopathy Macular edema Wet macular degeneration |
25 Aug 2022 | Bioeq/Teva Pharma |
| Retacrit | epoetin zeta |
Anaemia Autologous blood transfusion Cancer Chronic kidney failure |
18 Dec 2007 | Hospira (Pfizer) |
| Rimmyrah | ranibizumab |
Neovascular (wet) age-related macular degeneration (AMD) Visual impairment due to diabetic macular oedema (DME) Proliferative diabetic retinopathy (PDR) Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) Visual impairment due to choroidal neovascularisation (CNV) |
5 Jan 2024 | Qilu Pharma |
| Rixathon | rituximab |
Chronic B-cell ly+C85mphocytic leukaemia Microscopic polyangiitis Non-Hodgkin Lymphoma Rheumatoid arthritis Wegener granulomatosis |
15 Jun 2017 | Sandoz |
| Riximyo | rituximab |
Chronic B-cell lymphocytic leukaemia Microscopic polyangiitis Non-Hodgkin Lymphoma Rheumatoid arthritis Wegener granulomatosis |
15 Jun 2017 | Sandoz |
| Rolcya | denosumab |
Bone loss Osteoporosis |
CHMP positive opinion 23 May 2025 | Sandoz |
| Ruxience | rituximab |
Chronic lymphocytic leukaemia Granulomatosis with polyangiitis Microscopic polyangiitis Non-Hodgkin Lymphoma Rheumatoid arthritis Pemphigus vulgaris |
1 Apr 2020 | Pfizer |
| Semglee | insulin glargine | Diabetes mellitus | 28 Mar 2018 | Biocon/Viatris (formerly Mylan) |
| Silapo | epoetin zeta |
Anaemia Autologous blood transfusion Cancer Chronic kidney failure |
18 Dec 2007 | Stada Arzneimittel |
| Sondelbay | teriparatide | Osteoporosis | 24 Mar 2022 | Accord Healthcare |
| Steqeyma | ustekinumab |
Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis |
22 Aug 2024 | Celltrion |
| Stimufend | pegfilgrastim | Neutropenia | 24 Mar 2022 | Fresenius Kabi |
| Stoboclo | denosumab |
Bone resorption Osteoporosis Postmenopausal osteoporosis |
14 Feb 2025 | Celltrion |
| Terrosa | teriparatide | Osteoporosis | 4 Jan 2017 | Gedeon Richter |
| Tevagrastim | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
15 Sep 2008 | Teva Generics |
| Tofidence | tocilizumab |
Polyarticular juvenile idiopathic arthritis Rheumatoid arthritis Systemic juvenile idiopathic arthritis |
20 Jun 2024 | Biogen |
| Trazimera | trastuzumab |
Stomach Neoplasms Breast Neoplasms |
26 Jul 2018 | Pfizer |
| Truvelog Mix 30 | insulin aspart | Diabetes mellitus | Apr 2022 | Sanofi-Aventis |
| Truxima | rituximab |
Chronic lymphocytic leukaemia Granulomatosis with polyangiitis Microscopic polyangiitis Non-Hodgkin’s lymphoma Rheumatoid arthritis |
17 Feb 2017 | Celltrion Healthcare |
| Tuznue | trastuzumab |
Breast cancer Metastatic gastric cancer |
19 Sep 2024 | Prestige Biopharma Belgium BVBA |
| Tyenne | tocilizumab |
Active systemic juvenile idiopathic arthritis Chimeric antigen receptor T cell-induced cytokine release syndrome COVID-19 Giant cell arteritis Juvenile idiopathic polyarthritis |
15 Sep 2023 | Fresenius Kabi Deutschland GmbH |
| Tyruko | natalizumab |
Multiple sclerosis Relapsing-remitting multiple sclerosis |
26 Sep 2023 | Sandoz GmbH |
| Uzpruvo | ustekinumab |
Plaque psoriasis Paediatric plaque psoriasis Psoriatic arthritis (PsA) Crohn’s Disease |
5 Jan 2024 | Alvotech/Stada Arzneimittel AG |
| Vegzelma | bevacizumab |
Breast neoplasms Colorectal neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Renal cell carcinoma |
17 Aug 2022 | Celltrion Healthcare |
| Vevzuo | denosumab |
Giant cell tumour of bone Prevention of skeletal related events |
CHMP positive opinion 25 Apr 2025 | Biosimilar Collaborations Ireland Ltd |
| Wezenla | ustekinumab |
Crohn’s disease Plaque psoriasis, including paediatric plaque psoriasis Psoriatic arthritis |
20 Jun 2024 | Amgen |
| Wyost | denosumab |
Giant cell tumor of bone Neoplasms, Bone tissue |
16 May 2024 | Sandoz GmbH |
| Ximluci | ranibizumab |
Diabetes complications Diabetic retinopathy Macular edema Wet macular degeneration |
9 Nov 2022 | Stada Arzneimittel/Xbrane Biopharma |
| Xbryk | denosumab |
Giant cell tumor of bone Neoplasms, Bone tissue |
12 Feb 2025 | Samsung Bioepis |
| Yaxwer | denosumab |
Giant cell tumour of bone Prevention of skeletal related events |
CHMP positive opinion 25 Apr 2025 | Gedeon Richter |
| Yesafili | aflibercept |
Degenerative diabetes complications Diabetic retinopathy myopia Macular oedema Retinal vein occlusion |
15 Sep 2023 | Biocon/Viatris (formerly Mylan) |
| Yesintek | ustekinumab |
Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis (PsA) |
14 Feb 2025 | Biocon |
| Yuflyma | adalimumab |
Axial spondyoarthritis Crohn’s Disease Juvenile idiopathic arthritis Hidradenitis suppurativa Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis Uveitis |
11 Feb 2021 | Celltrion Healthcare |
| Zadenvi | denosumab |
Bone loss Osteoporosis |
CHMP positive opinion 25 Apr 2025 | Zentiva |
| Zarzio | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
6 Feb 2009 | Sandoz |
| Zefylti | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
12 Feb 2025 | CuraTeQ Biologics (Aurobindo) |
| Zercepac | trastuzumab |
Stomach Neoplasms Breast Neoplasms |
27 Jul 2020 | Accord Healthcare |
| Zessly | infliximab |
Ankylosing spondylitis Crohn’s disease Psoriatic arthritis psoriasis Rheumatoid arthritis Ulcerative colitis |
18 May 2018 | Sandoz |
| Ziextenzo | pegfilgrastim | Neutropenia | 22 Nov 2018 | Sandoz |
| Zirabev | bevacizumab |
Breast neoplasms Colorectal neoplasms Non-small-cell lung carcinoma Renal cell carcinoma Uterine cervical neoplasms |
14 Feb 2019 | Pfizer |
|
*Data updated on 20 June 2025 CHMP: Committee for Medicinal Products for Human Use; IVF: in vitro fertilization. Source: EMA |
By the end of June 2025, 18 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
• one for a denosumab biosimilar: Skojoy from Amgen in 20258
| Table 2: EMA refused/withdrawn biosimilars* |
| Product name | Active substance | Therapeutic area | Authorization date |
Manufacturer/ Company name |
| Alpheon | interferon alfa-2a | Chronic hepatitis C | Refused 5 Sep 2006 | BioPartners |
| Biograstim | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
15 Sep 2008 Withdrawn on 22 Dec 2016 |
CT Arzneimittel |
| Cavoley | pegfilgrastim | Neutropenia | Withdrawn on 20 Dec 2018 | Stada Artnimettel |
| Cyltezo | adalimumab |
Crohn’s disease Hidradenitis suppurativa Juvenile idiopathic arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis Uveitis |
10 Nov 2017 Withdrawn on 15 Jan 2019 | Boehringer Ingelheim |
| Efgratin | pegfilgrastim | Neutropenia | Withdrawn on 16 Nov 2016 | Gedeon Richter |
| Epostim | epoetin alfa | Anaemia | Withdrawn 15 Mar 2011 | Reliance GeneMedix |
| Equidacent | bevacizumab |
Breast neoplasms Colorectal neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Renal cell carcinoma |
24 Sep 2020 Withdrawn on 23 Nov 2021 | Centus Biotherapeutics |
| Filgrastim ratiopharm | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
15 Sep 2008 Withdrawn on 20 Apr 2011 |
Ratiopharm |
| Halimatoz | adalimumab |
Ankylosing spondylitis Hidradenitis suppurativa Juvenile rheumatoid arthritis Psoriatic arthritis Psoriasis Rheumatoid arthritis Uveitis |
26 Jul 2018 Withdrawn on 29 Jan 2021 |
Sandoz |
| Inpremzia | insulin human | Diabetes |
25 Apr 2022 Withdrawn on 20 Apr 2023 |
|
| Kromeya | adalimumab |
Ankylosing spondylitis Arthritis Crohn’s Disease Hidradenitis suppurativa Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis Uveitis |
2 Apr 2019 Withdrawn on 17 Dec 2019 |
Fresenius Kabi |
| Lextemy | bevacizumab |
Breast cancer Carcinoma of the cervix Colon cancer Fallopian tube cancer Non-small-cell lung carcinoma Ovarian cancer Peritoneal cancer Renal cell cancer |
CHMP positive opinion 25 Feb 2021 Withdrawn on 14 Dec 2021 |
Mylan (now Viatris) |
| Lusduna | insulin glargine | Diabetes |
3 Jan 2017 Withdrawn on 29 Oct 2018 |
Merck (MSD) |
| Qutavina | teriparatide | Osteoporosis |
27 Aug 2020 Withdrawn on 18 Jan 2021 |
EuroGenerics Holdings |
| Ritemvia | rituximab |
Wegener granulomatosis Microscopic polyangiitis Non-Hodgkin Lymphoma |
13 Jul 2017 Withdrawn on 16 Aug 2021 |
Celltrion |
| Rituximab Mabion | rituximab |
Chronic lymphocytic leukaemia Granulomatosis with polyangiitis Microscopic polyangiitis Non-Hodgkin Lymphoma |
Withdrawn on 16 Mar 2020 | Mabion |
| Rituzena (previously Tuxella) | rituximab |
Wegener granulomatosis Microscopic polyangiitis Non-Hodgkin Lymphoma Chronic B-cell lymphocytic leukaemia |
13 Jul 2017 Withdrawn on 10 Apr 2019 |
Celltrion |
| Skojoy | aflibercept |
Choroidal Neovascularization Macular Edema Retinal Vein Occlusion Wet Macular Degeneration |
CHMP positive opinion 30 Jan 2025 Withdrawn on 12 Mar 2025 |
Amgen |
| Solumarv | insulin human | Diabetes | Refused 11 Feb 2016 | Marvel Lifesciences |
| Solymbic | adalimumab |
Ankylosing spondylitis Crohn’s disease Hidradenitis suppurativa Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis |
22 Mar 2017 Withdrawn on 5 Mar 2019 |
Amgen |
| Somatropin Biopartners | somatropin |
Pituitary dwarfism Turner syndrome |
9 Sep 2013 Withdrawn on 9 Nov 2017 |
BioPartners |
| Thorinane | enoxaparin sodium | Venous thromboembolism |
14 Sep 2016 Withdrawn on 24 Oct 2019 |
Pharmathen |
| Udenyca | pegfilgrastim | Neutropenia |
21 Sep 2018 Withdrawn on 15 Feb 2021 |
ERA Consulting (Coherus Biosciences) |
| Valtropin | somatropin |
Pituitary dwarfism Turner syndrome |
24 Apr 2006 Withdrawn on 10 May 2012 |
BioPartners |
|
*Data updated on 20 June 2025 Source: EMA |
Additionally, four biosimilars were withdrawn before gaining approval, and two were refused approval. These biosimilars fall into the following therapeutic classes: 1) human growth hormone; 2) granulocyte colony-stimulating factor; 3) erythropoiesis stimulating agent; 4) insulin; 5) parathyroid hormone; and 6) monoclonal antibody.
The four biosimilars withdrawn before approval were: 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 refused by the agency were Alpheon (an interferon alfa-2a biosimilar) from Biopartners; and Solumarv (a human insulin biosimilar) from Marvel Lifesciences, see Table 2.
This leaves a total of 126 biosimilars approved for use in Europe.
The positive opinion reached by the EMA’s 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 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.
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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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Source: EMA
Dear Alexis Vaujany,
Thank you for your valuable comment received on 20/9/2021. We have updated the article tables of ‘Biosimilars approved in Europe’ with the correct information.
We very much appreciate your kind feedback. Thank you for your interest in GaBI, and please continue with your valuable comments to GaBI Online.
Best Regards, Anthika
It seems that Thorinane's MA was withdrawn in 2019 because it has not been marketed in the European Union in the three years following the granting of the authorisation.
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