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 126 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, Sandoz received 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 17 October 2024, Accord received a positive opinion from EMA’s CHMP for its biosimilar ustekinumab under two brand names – Absimky/Imuldosa (DMB-3115) [3].
On 19 March 2024, Dr Reddy’s Laboratories announced that it would be launching Versavo, a bevacizumab biosimilar, in the UK [4]. 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 [5].
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
|
CHMP positive opinion 17 Oct 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)
|
CHMP positive opinion 19 Sep 2024
|
Sandoz
|
Ahzantive/Baiama (FYB203)
|
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
|
CHMP positive opinion 14 Nov 2024
|
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)
|
CHMP positive opinion 12 Dec 2024
|
Celltrion
|
Avzivi
|
bevacizumab
|
Carcinoma, non-small-cell lung
Carcinoma, renal cell
Colorectal neoplasms
Fallopian tube neoplasms
Ovarian neoplasms
Peritoneal neoplasms Uterine cervical neoplasms
|
26 July 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
|
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
|
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
|
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 (CT-P42)
|
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
|
CHMP positive opinion 12 Dec 2024
|
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
|
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
|
CHMP positive opinion 17 Oct 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
|
CHMP positive opinion 25 Jul 2024
|
Reddy Holding
|
Jubbonti
|
denosumab
|
Bone resorption
Osteoporosis Postmenopausal osteoporosis
|
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
|
Obodence
|
denosumab
|
Bone resorption
Osteoporosis Postmenopausal osteoporosis
|
14 Nov 2024
|
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)
|
CHMP positive opinion 19 Sep 2024
|
Samsung Bioepis
|
Osenvelt
|
denosumab
|
Giant cell tumor of bone Neoplasms, Bone tissue
|
12 Dec 2024
|
Celltrion
|
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
|
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
|
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
|
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
|
CHMP positive opinion 12 Dec 2024
|
|
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
|
CHMP positive opinion 25 July 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
|
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
|
14 Nov 2024
|
Samsung Bioepis
|
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)
|
CHMP positive opinion 12 Dec 2024
|
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
|
Zarzio
|
filgrastim
|
Cancer
Haematopoietic stem cell transplantation Neutropenia
|
6 Feb 2009
|
Sandoz
|
Zefylti
|
filgrastim
|
Cancer
Haematopoietic stem cell transplantation Neutropenia
|
CHMP positive opinion 12 Dec 2024
|
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
|
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
|
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.
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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