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Biosimilars approved in Europe Posted 08/07/2011

Last update: 12 February 2021 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 77 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: EU approved biosimilars* Product name Active substance Therapeutic area Authorization date Manufacturer/Company name Abasaglar (previously Abasria)
insulin Diabetes 9 Sep 2014
Eli Lilly/Boehringer Abseamed epoetin alfa
Anaemia 27 Aug 2007 Medice Arzneimittel Pütter Accofil filgrastim Neutropenia 17 Sep 2014 Accord Healthcare Amgevita adalimumab
Ankylosing spondylitis 21 Mar 2017 Amgen Amsparity adalimumab
Ankylosing spondylitis 13 Feb 2020 Pfizer Aybintio bevacizumab
Breast neoplasms 19 Aug 2020 Samsung Bioepis Bemfola follitropin alfa Anovulation (IVF) 26 Mar 2014 Finox Biotech Benepali etanercept
Axial spondyloarthritis 13 Jan 2016 Samsung Bioepis Binocrit epoetin alfa
Anaemia 28 Aug 2007 Sandoz Blitzima rituximab
Non-Hodgkin lymphoma 13 Jul 2017 Celltrion Cegfila (previously Pegfilgrastim Mundipharma) pegfilgrastim Neutropenia 19 Dec 2019 Mundipharma Biologics Enoxaparin BECAT enoxaparin sodium Venous thromboembolism 24 March 2017 Laboratorios ROVI Epoetin alfa Hexal epoetin alfa
Anaemia 27 Aug 2007 Hexal Equidacent bevacizumab
Breast neoplasms 24 Sep 2020 Centus Biotherapeutics Erelzi etanercept
Ankylosing spondylitis 23 Jun 2017 Sandoz Filgrastim Hexal filgrastim
Cancer 6 Feb 2009 Hexal Flixabi infliximab
Ankylosing spondylitis 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) Halimatoz adalimumab
Ankylosing spondylitis 26 Jul 2018 Sandoz Hefiya adalimumab
Ankylosing spondylitis 26 Jul 2018 Sandoz Herzuma trastuzumab
Early breast cancer 8 Feb 2018 Celltrion Healthcare Hulio adalimumab
Ankylosing spondylitis 16 Sep 2018 Mylan/Fujifilm Kyowa Kirin Biologics Hyrimoz adalimumab
Ankylosing spondylitis 26 Jul 2018 Sandoz Idacio adalimumab
Ankylosing spondylitis 24 Apr 2019 Fresenius Kabi Imraldi adalimumab
Ankylosing spondylitis 24 Aug 2017 Samsung Bioepis Inflectra infliximab
Ankylosing spondylitis 10 Sep 2013 Hospira 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 16 May 2018 Amgen/Allergan Kixelle insulin aspart Diabetes mellitus CHMP positive opinion 10 Dec 2020 Mylan Livogiva teriparatide Osteoporosis 27 Aug 2020 Theramex Ireland Movymia teriparatide Osteoporosis 11 Jan 2017 Stada Arzneimittel Mvasi bevacizumab
Breast neoplasms Fallopian tube neoplasms 15 Jan 2018 Amgen Nepexto etanercept
Ankylosing spondylitis 25 May 2020 Mylan Nivestim filgrastim
Cancer 7 Jun 2010 Hospira (Pfizer) Nyvepria pegfilgrastim Neutropenia 18 Nov 2020 Pfizer Ogivri trastuzumab
Early breast cancer 12 Dec 2018 Biocon/Mylan Omnitrope somatropin
Pituitary dwarfism 12 Apr 2006 Sandoz Onbevzi bevacizumab
"Breast neoplasms Colorectal neoplasms CHMP positive opinion 21 Nov 2020 Samsung Bioepis Ontruzant trastuzumab
Early breast cancer 15 Nov 2017 Samsung Bioepis Ovaleap follitropin alfa Anovulation (IVF) 27 Sep 2013 Teva Pharma Pelgraz pegfilgrastim Neutropenia 20 Sep 2018 Accord Healthcare Pelmeg pegfilgrastim Neutropenia 20 Nov 2018 Cinfa Biotech/Mundipharma Qutavina teriparatide Osteoporosis 27 Aug 2020 EuroGenerics Holdings Ratiograstim filgrastim
Cancer 15 Sep 2008 Ratiopharm Remsima infliximab
Ankylosing spondylitis 10 Sep 2013 Celltrion Retacrit epoetin zeta
Anaemia 18 Dec 2007 Hospira Ritemvia rituximab
Wegener granulomatosis 13 Jul 2017 Celltrion Rixathon rituximab
Chronic B-cell lymphocytic leukaemia 15 Jun 2017 Sandoz Riximyo rituximab
Chronic B-cell lymphocytic leukaemia 15 Jun 2017 Sandoz Ruxience rituximab
Chronic lymphocytic leukaemia 1 Apr 2020 Pfizer Semglee insulin glargine Diabetes 28 Mar 2018 Mylan Silapo epoetin alfa
Anaemia 18 Dec 2007 Stada Arzneimittel Solymbic adalimumab
Ankylosing spondylitis 22 Mar 2017 Amgen Terrosa teriparatide Osteoporosis 4 Jan 2017 Gedeon Richter Tevagrastim filgrastim
Cancer 15 Sep 2008 Teva Generics Thorinane enoxaparin sodium Venous thromboembolism 14 Sep 2016 Pharmathen Trazimera trastuzumab
Stomach Neoplasms 26 Jul 2018 Pfizer Truxima rituximab
Chronic lymphocytic leukaemia 17 Feb 2017 Celltrion Udenyca pegfilgrastim Neutropenia 21 Sep 2018 ERA Consulting (Coherus Biosciences) Yuflyma adalimumab
Axial spondyoarthritis CHMP positive opinion 10 Dec 2020 Celltrion Healthcare Zarzio filgrastim
Cancer 6 Feb 2009 Sandoz Zercepac trastuzumab
"Stomach Neoplasms 27 Jul 2020 Accord Healthcare Zessly infliximab
Ankylosing spondylitis 18 May 2018 Sandoz Ziextenzo pegfilgrastim Neutropenia 22 Nov 2018 Sandoz Zirabev bevacizumab
Breast neoplasms 14 Feb 2019 Pfizer
*Data updated on 12 February 2021.
Eight biosimilar approvals have been withdrawn after approval, see Table 2: 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, see Table 2: an interferon alfa-2a biosimilar, Alpheon, from Biopartners, and a human insulin biosimilar, Solumarv, from Marvel Lifesciences. This leaves a total of 69 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
15 Sep 2008 CT Arzneimittel Cyltezo adalimumab
Crohn’s disease
10 Nov 2017 Boehringer Ingelheim Epostim epoetin alfa anaemia Withdrawn on 15 Mar 2011 Reliance GeneMedix Filgrastim ratiopharm filgrastim
Cancer
15 Sep 2008 Ratiopharm Kromeya adalimumab
Ankylosing spondylitis
2 Apr 2019 Fresenius Kabi Lusduna insulin glargine Diabetes
3 Jan 2017 Merck (MSD) Mabion CD20 rituximab - Withdrawn on 16 April 2020 Mabion Rituzena (previously Tuxella) rituximab
Wegener granulomatosis
13 Jul 2017 Celltrion Solumarv insulin human Diabetes Refused 11 Feb 2016 Marvel Lifesciences Somatropin Biopartners somatropin
Pituitary dwarfism
9 Sep 2013 BioPartners Valtropin somatropin
Pituitary dwarfism
24 Apr 2006 BioPartners
*Data updated on 12 February 2021. 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.
Related articles EMA approves first monoclonal antibody biosimilar Biosimilar monoclonal antibody approved in Korea
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glargine
Ingelheim
Cancer
Chronic kidney failure
Crohn’s disease
Juvenile rheumatoid arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Hidradenitis Suppurativa
Crohn’s disease
Juvenile rheumatoid arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
Colorectal neoplasms
Fallopian tube neoplasms
Non-small-cell lung carcinoma
Ovarian neoplasms
Peritoneal neoplasms
Renal cell carcinoma
Uterine cervical neoplasms
Psoriatic arthritis
Plaque psoriasis
Rheumatoid arthritis
Chronic kidney failure
Chronic B-cell lymphocytic leukaemia
Cancer
Chronic kidney failure
Colorectal neoplasms
Non-small-cell lung carcinoma
Ovarian neoplasms
Renal cell carcinoma
Juvenile rheumatoid arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Haematopoietic stem cell transplantation
Neutropenia
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Hidradenitis suppurativa
Juvenile rheumatoid arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Uveitis
Hidradenitis suppurativa
Juvenile rheumatoid arthritis
Psoriasis
Uveitis
Metastatic breast cancer
Metastatic gastric cancer
Crohn’s Disease
Hidradenitis suppurativa
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative Colitis
Uveitis
Crohn’s Disease
Hidradenitis suppurativa
Juvenile rheumatoid arthritis
Papulosquamous skin disease
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative Colitis
Uveitis
Arthritis
Crohn’s Disease
Hidradenitis suppurativa
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
Arthritis
Crohn’s Disease
Hidradenitis suppurativa
Psoriatic arthritis,
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Metastatic breast cancer
Metastatic gastric cancer
Non-small-cell lung carcinoma
Ovarian neoplasms
Peritoneal neoplasms
Renal cell carcinoma
Juvenile rheumatoid arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Spondylarthropathies
Haematopoietic stem cell transplantation
Neutropenia
Metastatic breast cancer
Metastatic gastric cancer
Prader-Willi syndrome
Turner syndrome
Fallopian tube neoplasms
Non-small-cell lung carcinoma
Ovarian neoplasms
Peritoneal neoplasms
Renal cell carcinoma
Uterine Cervical Neoplasms"
Metastatic breast cancer
Metastatic gastric cancer
Haematopoietic stem cell transplantation
Neutropenia
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Autologous blood transfusion
Cancer
Chronic kidney failure
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Rheumatoid arthritis
Wegener granulomatosis
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Rheumatoid arthritis
Wegener granulomatosis
Granulomatosis with polyangiitis
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Rheumatoid arthritis
Pemphigus vulgaris
Autologous blood transfusion
Cancer
Chronic kidney failure
Crohn’s disease
Hidradenitis suppurativa
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Haematopoietic stem cell transplantation
Neutropenia
Breast Neoplasms
Granulomatosis with polyangiitis
Microscopic polyangiitis
Non-Hodgkin’s lymphoma
Rheumatoid arthritis
Crohn’s Disease
Juvenile idiopathic arthritis
Hidradenitis suppurativa
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
Haematopoietic stem cell transplantation
Neutropenia
Breast Neoplasms"
Crohn’s disease
Psoriatic arthritis
psoriasis
Rheumatoid arthritis
Ulcerative colitis
Colorectal neoplasms
Non-small-cell lung carcinoma
Renal cell carcinoma
Uterine cervical neoplasms
CHMP: Committee for Medicinal Products for Human Use; IVF: in vitro fertilization.
Source: EMA.
• two for filgrastim biosimilars: Filgrastim ratiopharm in April 2011 and CT Arzneimittel’s Biograstim in December 2016
• one 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
• two for adalimumab biosimilars: Boehringer Ingelheim’s Cyltezo in January 2019 and Fresenius Kabi’s Kromeya in December 2019
• one for a rituximab biosimilar: Celltrion’s Rituzena in April 2019
Haematopoietic stem cell transplantation
Neutropenia
Withdrawn on 22 Dec 2016
Hidradenitis suppurativa
Juvenile idiopathic arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
Withdrawn on 15 Jan 2019
Haematopoietic stem cell transplantation
Neutropenia
Withdrawn 20 Apr 2011
Arthritis
Crohn’s Disease
Hidradenitis suppurativa
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
Withdrawn on 17 Dec 2019
Withdrawn on 29 Oct 2018
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Chronic B-cell lymphocytic leukaemia
Withdrawn on 10 Apr 2019
Turner syndrome
Withdrawn on 9 Nov 2017
Turner syndrome
Withdrawn on 14 Aug 2012
Source: EMA.
Remsima approved in Colombia
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
Source: EMA
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