Biosimilars approved in Europe Posted 08/07/2011
Last update: 14 December 2018 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 approved 58 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoiesis stimulating agent, insulin, follicle-stimulating hormone (FSH), parathyroid hormone, tumour necrosis factor (TNF)-inhibitor and monoclonal antibody, for use in the EU, see Table 1. Four biosimilar approvals have been withdrawn; two for filgrastim biosimilars: Filgrastim ratiopharm in April 2011 and Biograstim in December 2016, and two for somatropin biosimilars: Valtropin in May 2012 and Somatropin Biopartners in December 2017. This leaves a total of 54 biosimilars approved for use in Europe. 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 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 Biograstim filgrastim
Cancer
15 Sep 2008 CT Arzneimittel Blitzima rituximab
Non-Hodgkin lymphoma 13 Jul 2017 Celltrion Cyltezo adalimumab
Crohn’s disease 10 Nov 2017 Boehringer Ingelheim 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 Filgrastim ratiopharm filgrastim
Cancer
15 Sep 2008 Ratiopharm Flixabi infliximab
Ankylosing spondylitis 26 May 2016 Samsung Bioepis Fulphila pegfilgrastim Neutropenia CHMP positive opinion 20 Sep 2018 Mylan Grastofil filgrastim Neutropenia 18 Oct 2013 Apotex Halimatoz adalimumab
Ankylosing spondylitis 26 Jul 2018 Sandoz Hefiya adalimumab
Ankylosing spondylitis 26 Jul 2018 Sandoz Hulio adalimumab
Ankylosing spondylitis 17 Sep 2018 Mylan/Fujifilm Kyowa Kirin Biologics Hyrimoz adalimumab
Ankylosing spondylitis 26 Jul 2018 Sandoz Herzuma trastuzumab
Early breast cancer 9 Feb 2018 Celltrion Healthcare 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 Lusduna insulin glargine Diabetes 4 Jan 2017 Merck (MSD) 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 CHMP positive opinion 18 Oct 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 CHMP positive opinion 26 Jul 2018 Accord Healthcare Pelmeg pegfilgrastim Neutropenia 23 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 Rituzena (previously Tuxella) 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 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 Somatropin Biopartners somatropin
Pituitary dwarfism
9 Sep 2013 BioPartners 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) Valtropin somatropin
Pituitary dwarfism
24 Apr 2006 BioPartners Zarzio filgrastim
Cancer 6 Feb 2009 Sandoz Zessly infliximab
Ankylosing spondylitis 24 May 2018 Sandoz Ziextenzo pegfilgrastim Neutropenia 27 Nov 2018 Sandoz
*Data collected on 12 May 2011, updated on 14 December 2018 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. 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 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].
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glargine
Ingelheim
Cancer
Chronic kidney failure
Crohn’s disease
Juvenile rheumatoid arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Psoriatic arthritis
Plaque psoriasis
Rheumatoid arthritis
Chronic kidney failure
Haematopoietic stem cell transplantation
Neutropenia
Withdrawn on 22 Dec 2016
Chronic B-cell lymphocytic leukaemia
Hidradenitis suppurativa
Juvenile idiopathic arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Uveitis
Cancer
Chronic kidney failure
Juvenile rheumatoid arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Haematopoietic stem cell transplantation
Neutropenia
Haematopoietic stem cell transplantation
Neutropenia
Withdrawn on 20 Apr 2011
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
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
Metastatic breast cancer
Metastatic gastric cancer
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
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
Chronic B-cell lymphocytic leukaemia
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Rheumatoid arthritis
Wegener granulomatosis
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Rheumatoid arthritis
Wegener granulomatosis
Autologous blood transfusion
Cancer
Chronic kidney failure
Crohn’s disease
Hidradenitis suppurativa
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Turner syndrome
Withdrawn on 1 Dec 2017
Haematopoietic stem cell transplantation
Neutropenia
Breast Neoplasms
Granulomatosis with polyangiitis
Microscopic polyangiitis
Non-Hodgkin’s lymphoma
Rheumatoid arthritis
Turner syndrome
Withdrawn on 10 May 2012
Haematopoietic stem cell transplantation
Neutropenia
Crohn’s disease
Psoriatic arthritis
psoriasis
Rheumatoid arthritis
Ulcerative colitis
CHMP: Committee for Medicinal Products for Human Use; VF: in vitro fertilization.
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