Biosimilars approved in Europe Posted 08/07/2011
Last update: 21 February 2020 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 66 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 Diabetes 9 Sep 2014
Eli Lilly/Boehringer Abseamed epoetin alfa
Anaemia 28 Aug 2007 Medice Arzneimittel Pütter Accofil filgrastim Neutropenia 18 Sep 2014 Accord Healthcare Amgevita adalimumab
Ankylosing spondylitis 22 Mar 2017 Amgen Amsparity adalimumab
Ankylosing spondylitis 13 Feb 2020 Pfizer Benepali etanercept
Axial spondyloarthritis 14 Jan 2016 Samsung Bioepis Bemfola follitropin alfa Anovulation (IVF) 24 Mar 2014 Finox Biotech 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 Epoetin alfa Hexal epoetin alfa
Anaemia 28 Aug 2007 Hexal Erelzi etanercept
Ankylosing spondylitis 27 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 Grasustek pegfilgrastim Neutropenia 20 Jun 2019 Juta Pharma (USV) Grastofil filgrastim Neutropenia 18 Oct 2013 Apotex Halimatoz adalimumab
Ankylosing spondylitis 26 Jul 2018 Sandoz Hefiya adalimumab
Ankylosing spondylitis 26 Jul 2018 Sandoz Herzuma trastuzumab
Early breast cancer 9 Feb 2018 Celltrion Healthcare Hulio adalimumab
Ankylosing spondylitis 17 Sep 2018 Mylan/Fujifilm Kyowa Kirin Biologics Hyrimoz adalimumab
Ankylosing spondylitis 26 Jul 2018 Sandoz Idacio adalimumab
Ankylosing spondylitis 2 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 lispro Sanofi insulin lispro Diabetes mellitus 19 Jul 2017 Sanofi-Aventis Kanjinti trastuzumab
Early breast cancer 16 May 2018 Amgen/Allergan Kromeya adalimumab
Ankylosing spondylitis 2 Apr 2019 Fresenius Kabi Movymia teriparatide Osteoporosis 11 Jan 2017 Stada Arzneimittel Mvasi bevacizumab
Breast neoplasms Fallopian tube neoplasms 15 Jan 2018 Amgen Nivestim filgrastim
Cancer 8 Jun 2010 Hospira (Pfizer) Ogivri trastuzumab
Early breast cancer 12 Dec 2018 Biocon/Mylan Omnitrope somatropin
Pituitary dwarfism 12 Apr 2006 Sandoz 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 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 19 Jun 2017 Sandoz Riximyo rituximab
Chronic B-cell lymphocytic leukaemia 15 Jun 2017 Sandoz Ruxience rituximab
Chronic lymphocytic leukaemia CHMP positive opinion 30 Jan 2020 Pfizer Semglee insulin glargine Diabetes 28 Mar 2018 Mylan Silapo epoetin zeta
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 15 Sep 2016 Pharmathen Trazimera trastuzumab
Stomach Neoplasms 26 Jul 2018 Pfizer Truxima rituximab
Chronic lymphocytic leukaemia 17 Feb 2017 Celltrion Udenyca pegfilgrastim Neutropenia 20 Sep 2018 ERA Consulting (Coherus Biosciences) Zarzio filgrastim
Cancer 6 Feb 2009 Sandoz Zessly infliximab
Ankylosing spondylitis 18 May 2018 Sandoz Ziextenzo pegfilgrastim Neutropenia 27 Nov 2018 Sandoz Zirabev bevacizumab
Breast neoplasms 14 Feb 2019 Pfizer
*Data collected on 12 May 2011, updated on 21 February 2020
Six biosimilar approvals have been withdrawn after approval, see Table 2: One biosimilar was withdrawn before approval, see Table 2: Reliance GeneMedix’s epoetin alfa biosimilar, Epostim. 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 59 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 15 Mar 2011 Reliance GeneMedix Filgrastim ratiopharm filgrastim
Cancer
15 Sep 2008 Ratiopharm Lusduna insulin glargine Diabetes
4 Jan 2017 Merck (MSD) Rituzena (previously Tuxella) rituximab
Wegener granulomatosis
13 Jul 2017 Celltrion Solumarv insulin human Diabetes Refused 11 Feb 2016 Marvel Lifesciences Valtropin somatropin
Pituitary dwarfism
24 Apr 2006 BioPartners
*Data collected on 21 February 2020 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
Psoriatic arthritis
Plaque psoriasis
Rheumatoid arthritis
Chronic kidney failure
Chronic B-cell lymphocytic leukaemia
Cancer
Chronic kidney failure
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
Arthritis
Crohn’s Disease
Hidradenitis suppurativa
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
Non-small-cell lung carcinoma
Ovarian neoplasms
Peritoneal neoplasms
Renal cell carcinoma
Haematopoietic stem cell transplantation
Neutropenia
Metastatic breast cancer
Metastatic gastric cancer
Prader-Willi syndrome
Turner syndrome
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
Haematopoietic stem cell transplantation
Neutropenia
Crohn’s disease
Psoriatic arthritis
psoriasis
Rheumatoid arthritis
Ulcerative colitis
Colorectal neoplasms
Non-small-cell lung carcinoma
Uterine cervical neoplasms
Renal cell carcinoma
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 a somatropin biosimilar: Biopartner’s Valtropin in May 2012
• one for an insulin glargine biosimilar: Merck’s Lusduna in October 2018
• one for an adalimumab biosimilar: Boehringer Ingelheim’s Cyltezo in January 2019
• one for a rituximab biosimilar: Celltrion’s Rituzena in April 2019
Haematopoietic stem cell transplantation
Neutropenia
Withdrawn 22 Dec 2016
Hidradenitis suppurativa
Juvenile idiopathic arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
Withdrawn 15 Jan 2019
Haematopoietic stem cell transplantation
Neutropenia"Cancer
Haematopoietic stem cell transplantation
Neutropenia
Withdrawn 20 Apr 2011
Withdrawn 29 Oct 2018
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Chronic B-cell lymphocytic leukaemia
Withdrawn 10 Apr 2019
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