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Last update: 16 July 2024
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 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].
| 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 |
| 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 |
| Avzivi | bevacizumab |
Carcinoma, non-small-cell lung Carcinoma, renal cell Colorectal neoplasms Fallopian tube neoplasms Ovarian neoplasms Peritoneal neoplasms Uterine cervical neoplasms |
CHMP positive opinion 30 May 2024 | Bio-Thera Solutions |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Jubbonti | denosumab |
Osteoporosis Postmenopausal osteoporosis Bone resorption |
16 May 2024 | Sandoz GmbH |
| 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 |
| 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 |
| 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 |
| 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 |
| Pyzchiva | ustekinumab |
Crohn’s disease Paediatric plaque psoriasis Psoriatic arthritis Ulcerative colitis |
22 Apr 2024 | Samsung Bioepis |
| 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 |
| 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 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 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 |
| Stimufend | pegfilgrastim | Neutropenia | 24 Mar 2022 | Fresenius Kabi |
| 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 |
CHMP positive opinion 25 Apr 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 |
| 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 |
| Wezenla | ustekinumab |
Crohn’s disease Plaque psoriasis, including paediatric plaque psoriasis Psoriatic arthritis |
CHMP positive opinion 25 Apr 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 |
| Yesafili | aflibercept |
Degenerative diabetes complications Diabetic retinopathy myopia Macular oedema Retinal vein occlusion |
15 Sep 2023 | Biocon/Viatris (formerly Mylan) |
| 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 16 July 2024 CHMP: Committee for Medicinal Products for Human Use; IVF: in vitro fertilization. Source: EMA |
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
| 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 |
| 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 16 July 2024 Source: EMA |
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.
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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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