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Last update: 1 July 2022
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 88 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; and 8) monoclonal antibodies for use in the EU, see Table 1.
| Table 1: EMA approved biosimilars* |
| Product name | Active substance | Therapeutic area | Authorization date |
Manufacturer/ Company name |
| Abasaglar (previously Abasria) | insulin glargine | Diabetes | 9 Sep 2014 | Eli Lilly/Boehringer Ingelheim |
| Abseamed | epoetin alfa |
Anaemia Cancer Chronic kidney failure |
27 Aug 2007 | Medice Arzneimittel Pütter |
| Accofil | filgrastim | Neutropenia | 17 Sep 2014 | Accord Healthcare |
| 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) |
| 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 |
| 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 |
| 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 |
| Enoxaparin BECAT | enoxaparin sodium | Venous thromboembolism | 24 Mar 2017 | Laboratorios ROVI |
| Epoetin alfa Hexal | epoetin alfa |
Anaemia Cancer Chronic kidney failure |
27 Aug 2007 | Hexal |
| Erelzi | etanercept |
Ankylosing spondylitis Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis |
23 Jun 2017 | Sandoz |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | Mylan (now Viatris)/ Biocon |
| 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 |
| Nivestim | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
7 Jun 2010 | Hospira (Pfizer) |
| Nyvepria | pegfilgrastim | Neutropenia | 18 Nov 2020 | Pfizer |
| Ogivri | trastuzumab |
Early breast cancer Metastatic breast cancer Metastatic gastric cancer |
12 Dec 2018 | Biocon/Mylan |
| 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 |
| 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 |
| Pelgraz | pegfilgrastim | Neutropenia | 21 Sep 2018 | Accord Healthcare |
| Pelmeg | pegfilgrastim | Neutropenia | 20 Nov 2018 | Cinfa Biotech/Mundipharma |
| 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 |
| Retacrit | epoetin zeta |
Anaemia Autologous blood transfusion Cancer Chronic kidney failure |
18 Dec 2007 | Hospira (Pfizer) |
| Rixathon | rituximab |
Chronic B-cell lymphocytic 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 |
| 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 | 28 Mar 2018 | Mylan |
| Silapo | epoetin zeta |
Anaemia Autologous blood transfusion Cancer Chronic kidney failure |
18 Dec 2007 | Stada Arzneimittel |
| Sondelbay | teriparatide | Osteoporosis | CHMP positive opinion 27 Jan 2022 | Accord Healthcare |
| Stimufend | pegfilgrastim | Neutropenia | CHMP positive opinion 27 Jan 2022 | Fresenius Kabi |
| Terrosa | teriparatide | Osteoporosis | 4 Jan 2017 | Gedeon Richter |
| Tevagrastim | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
15 Sep 2008 | Teva Generics |
| Trazimera | trastuzumab |
Stomach Neoplasms Breast Neoplasms |
26 Jul 2018 | Pfizer |
| Truxima | rituximab |
Chronic lymphocytic leukaemia Granulomatosis with polyangiitis Microscopic polyangiitis Non-Hodgkin’s lymphoma Rheumatoid arthritis |
17 Feb 2017 | Celltrion Healthcare |
| Vegzelma | bevacizumab |
Breast neoplasms Colorectal neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Renal cell carcinoma |
CHMP positive opinion 24 Jun 2022 | Celltrion Healthcare |
| 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 |
| Zarzio | filgrastim |
Cancer Haematopoietic stem cell transplantation Neutropenia |
6 Feb 2009 | Sandoz |
| 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 1 July 2022 CHMP: Committee for Medicinal Products for Human Use; VF: in vitro fertilization. Source: EMA |
Sixteen biosimilar approvals have been withdrawn after approval, see Table 2:
• two for filgrastim biosimilars: Filgrastim ratiopharm in April 2011 and CT Arzneimittel’s Biograstim in December 2016
• two for somatropin biosimilars: Biopartner’s Valtropin in May 2012 and Somatropin Biopartners in November 2017
• one for an insulin glargine biosimilar: Merck’s Lusduna in October 2018
• 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
• one for a teriparatide biosimilar: Qutavina from EuroGenerics Holdings in January 2018
• two for rituximab biosimilars: Celltrion’s Rituzena in April 2019 and Celltrion’s Ritemvia in August 2021
• one for an enoxaparin sodium biosimilar: Pharmathen’s Thorinane in October 2019
• one for a pegfilgrastim biosimilar: ERA Consulting’s (Coherus Biosciences) Udenyca in February 2021
• two for bevacizumab biosimilars: Equidacent from Centus Biotherapeutics in November 2021 and Mylan’s (now Viatris) Lextemy in December 2021
Two biosimilar were withdrawn before approval: Reliance GeneMedix’s epoetin alfa biosimilar, Epostim; and Mabion’s rituximab biosimilar, 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.
This leaves a total of 73 biosimilars approved for use in Europe.
| 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 |
| 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 |
| 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 |
| 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 |
| Solumarv | insulin human | Diabetes | Refused 11 Feb 2016 | Marvel Lifesciences |
| Sondelbay | teriparatide | Osteoporosis | Withdrawn on 19 Jun 2020 | Accord healthcare |
| 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 1 July 2022 Source: EMA |
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 [3].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.
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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. 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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