Last update: 12 May 2023
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 93 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 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
|
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
|
Paroxysmal nocturnal hemoglobinuria: adult and children
|
CHMP positive opinion 31 Mar 2023
|
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
|
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
|
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
|
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
|
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)
|
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
|
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
|
Vegzelma
|
bevacizumab
|
Breast neoplasms
Colorectal neoplasms
Non-small-cell lung carcinoma
Ovarian neoplasms Renal cell carcinoma
|
17 Aug 2022
|
Celltrion Healthcare
|
Ximluci
|
ranibizumab
|
Diabetes complications
Diabetic retinopathy
Macular edema Wet macular degeneration
|
9 Nov 2022
|
Stada Arzneimittel/Xbrane Biopharma
|
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 12 May 2023
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
|
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
|
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 12 May 2023 Source: EMA
|
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.
By end of February 2023, there is a total of 25 biosimilars withdrawn pre-approval, in the classes of: adalimumab (1); infliximab (1); insulin (6); pegfilgrastim (6, 2 resubmitted); teriparatide (2); trastuzumab (4), including one each of epoetin and rituximab mentioned above.
This leaves a total of 76 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 [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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