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 |
glargine | Ingelheim | |||
Abseamed | epoetin alfa | Anaemia | 27 Aug 2007 | Medice Arzneimittel Pütter |
Cancer | ||||
Chronic kidney failure | ||||
Accofil | filgrastim | Neutropenia | 17 Sep 2014 | Accord Healthcare |
Amgevita | adalimumab | Ankylosing spondylitis | 21 Mar 2017 | Amgen |
Crohn’s disease | ||||
Juvenile rheumatoid arthritis | ||||
Psoriasis | ||||
Psoriatic arthritis | ||||
Rheumatoid arthritis | ||||
Ulcerative colitis | ||||
Amsparity | adalimumab | Ankylosing spondylitis | 13-feb-20 | Pfizer |
Hidradenitis Suppurativa | ||||
Crohn’s disease | ||||
Juvenile rheumatoid arthritis | ||||
Psoriasis | ||||
Psoriatic arthritis | ||||
Rheumatoid arthritis | ||||
Ulcerative colitis | ||||
Uveitis | ||||
Aybintio | bevacizumab | Breast neoplasms | 19 Aug 2020 | Samsung Bioepis |
Colorectal neoplasms | ||||
Fallopian tube neoplasms | ||||
Non-small-cell lung carcinoma | ||||
Ovarian neoplasms | ||||
Peritoneal neoplasms | ||||
Renal cell carcinoma | ||||
Uterine cervical neoplasms | ||||
Bemfola | follitropin alfa | Anovulation (IVF) | 26-mar-14 | Finox Biotech |
Benepali | etanercept | Axial spondyloarthritis | 13 Jan 2016 | Samsung Bioepis |
Psoriatic arthritis | ||||
Plaque psoriasis | ||||
Rheumatoid arthritis | ||||
Binocrit | epoetin alfa | Anaemia | 28 Aug 2007 | Sandoz |
Chronic kidney failure | ||||
Blitzima | rituximab | Non-Hodgkin lymphoma | 13 Jul 2017 | Celltrion |
Chronic B-cell lymphocytic leukaemia | ||||
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 |
Cancer | ||||
Chronic kidney failure | ||||
Equidacent | bevacizumab | Breast neoplasms | 24 Sep 2020 | Centus Biotherapeutics |
Colorectal neoplasms | ||||
Non-small-cell lung carcinoma | ||||
Ovarian neoplasms | ||||
Renal cell carcinoma | ||||
Erelzi | etanercept | Ankylosing spondylitis | 23 Jun 2017 | Sandoz |
Juvenile rheumatoid arthritis | ||||
Psoriasis | ||||
Psoriatic arthritis | ||||
Rheumatoid arthritis | ||||
Filgrastim Hexal | filgrastim | Cancer | 06-feb-09 | Hexal |
Haematopoietic stem cell transplantation | ||||
Neutropenia | ||||
Flixabi | infliximab | Ankylosing spondylitis | 26 May 2016 | Samsung Bioepis |
Crohn’s disease | ||||
Psoriatic arthritis | ||||
Psoriasis | ||||
Rheumatoid arthritis | ||||
Ulcerative colitis | ||||
Fulphila | pegfilgrastim | Neutropenia | 20-nov-18 | 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 |
Hidradenitis suppurativa | ||||
Juvenile rheumatoid arthritis | ||||
Psoriatic arthritis | ||||
Psoriasis | ||||
Rheumatoid arthritis | ||||
Uveitis | ||||
Hefiya | adalimumab | Ankylosing spondylitis | 26 Jul 2018 | Sandoz |
Hidradenitis suppurativa | ||||
Juvenile rheumatoid arthritis | ||||
Psoriasis | ||||
Uveitis | ||||
Herzuma | trastuzumab | Early breast cancer | 08-feb-18 | Celltrion Healthcare |
Metastatic breast cancer | ||||
Metastatic gastric cancer | ||||
Hulio | adalimumab | Ankylosing spondylitis | 16 Sep 2018 | Mylan/Fujifilm Kyowa Kirin Biologics |
Crohn’s Disease | ||||
Hidradenitis suppurativa | ||||
Psoriasis | ||||
Psoriatic arthritis | ||||
Rheumatoid arthritis | ||||
Ulcerative Colitis | ||||
Uveitis | ||||
Hyrimoz | adalimumab | Ankylosing spondylitis | 26 Jul 2018 | Sandoz |
Crohn’s Disease | ||||
Hidradenitis suppurativa | ||||
Juvenile rheumatoid arthritis | ||||
Papulosquamous skin disease | ||||
Psoriatic arthritis | ||||
Rheumatoid arthritis | ||||
Ulcerative Colitis | ||||
Uveitis | ||||
Idacio | adalimumab | Ankylosing spondylitis | 24-apr-19 | Fresenius Kabi |
Arthritis | ||||
Crohn’s Disease | ||||
Hidradenitis suppurativa | ||||
Psoriatic arthritis | ||||
Psoriasis | ||||
Rheumatoid arthritis | ||||
Ulcerative colitis | ||||
Uveitis | ||||
Imraldi | adalimumab | Ankylosing spondylitis | 24 Aug 2017 | Samsung Bioepis |
Arthritis | ||||
Crohn’s Disease | ||||
Hidradenitis suppurativa | ||||
Psoriatic arthritis, | ||||
Psoriasis | ||||
Rheumatoid arthritis | ||||
Ulcerative colitis | ||||
Uveitis | ||||
Inflectra | infliximab | Ankylosing spondylitis | 10 Sep 2013 | Hospira |
Crohn’s disease | ||||
Psoriatic arthritis | ||||
Psoriasis | ||||
Rheumatoid arthritis | ||||
Ulcerative colitis | ||||
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 |
Metastatic breast cancer | ||||
Metastatic gastric cancer | ||||
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 |
Non-small-cell lung carcinoma | ||||
Ovarian neoplasms | ||||
Peritoneal neoplasms | ||||
Renal cell carcinoma | ||||
Nepexto | etanercept | Ankylosing spondylitis | 25 May 2020 | Mylan |
Juvenile rheumatoid arthritis | ||||
Psoriasis | ||||
Psoriatic arthritis | ||||
Rheumatoid arthritis | ||||
Spondylarthropathies | ||||
Nivestim | filgrastim | Cancer | 7 Jun 2010 | Hospira (Pfizer) |
Haematopoietic stem cell transplantation | ||||
Neutropenia | ||||
Nyvepria | pegfilgrastim | Neutropenia | 18-nov-20 | Pfizer |
Ogivri | trastuzumab | Early breast cancer | 12 Dec 2018 | Biocon/Mylan |
Metastatic breast cancer | ||||
Metastatic gastric cancer | ||||
Omnitrope | somatropin | Pituitary dwarfism | 12-apr-06 | Sandoz |
Prader-Willi syndrome | ||||
Turner syndrome | ||||
Onbevzi | bevacizumab | "Breast neoplasms Colorectal neoplasms | CHMP positive opinion 21 Nov 2020 | Samsung Bioepis |
Fallopian tube neoplasms | ||||
Non-small-cell lung carcinoma | ||||
Ovarian neoplasms | ||||
Peritoneal neoplasms | ||||
Renal cell carcinoma | ||||
Uterine Cervical Neoplasms" | ||||
Ontruzant | trastuzumab | Early breast cancer | 15-nov-17 | Samsung Bioepis |
Metastatic breast cancer | ||||
Metastatic gastric cancer | ||||
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 |
Haematopoietic stem cell transplantation | ||||
Neutropenia | ||||
Remsima | infliximab | Ankylosing spondylitis | 10 Sep 2013 | Celltrion |
Crohn’s disease | ||||
Psoriatic arthritis | ||||
Psoriasis | ||||
Rheumatoid arthritis | ||||
Ulcerative colitis | ||||
Retacrit | epoetin zeta | Anaemia | 18 Dec 2007 | Hospira |
Autologous blood transfusion | ||||
Cancer | ||||
Chronic kidney failure | ||||
Ritemvia | rituximab | Wegener granulomatosis | 13 Jul 2017 | Celltrion |
Microscopic polyangiitis | ||||
Non-Hodgkin Lymphoma | ||||
Rixathon | rituximab | Chronic B-cell lymphocytic leukaemia | 15 Jun 2017 | Sandoz |
Microscopic polyangiitis | ||||
Non-Hodgkin Lymphoma | ||||
Rheumatoid arthritis | ||||
Wegener granulomatosis | ||||
Riximyo | rituximab | Chronic B-cell lymphocytic leukaemia | 15 Jun 2017 | Sandoz |
Microscopic polyangiitis | ||||
Non-Hodgkin Lymphoma | ||||
Rheumatoid arthritis | ||||
Wegener granulomatosis | ||||
Ruxience | rituximab | Chronic lymphocytic leukaemia | 01-apr-20 | Pfizer |
Granulomatosis with polyangiitis | ||||
Microscopic polyangiitis | ||||
Non-Hodgkin Lymphoma | ||||
Rheumatoid arthritis | ||||
Pemphigus vulgaris | ||||
Semglee | insulin glargine | Diabetes | 28-mar-18 | Mylan |
Silapo | epoetin alfa | Anaemia | 18 Dec 2007 | Stada Arzneimittel |
Autologous blood transfusion | ||||
Cancer | ||||
Chronic kidney failure | ||||
Solymbic | adalimumab | Ankylosing spondylitis | 22-mar-17 | Amgen |
Crohn’s disease | ||||
Hidradenitis suppurativa | ||||
Psoriasis | ||||
Psoriatic arthritis | ||||
Rheumatoid arthritis | ||||
Ulcerative colitis | ||||
Terrosa | teriparatide | Osteoporosis | 4 Jan 2017 | Gedeon Richter |
Tevagrastim | filgrastim | Cancer | 15 Sep 2008 | Teva Generics |
Haematopoietic stem cell transplantation | ||||
Neutropenia | ||||
Thorinane | enoxaparin sodium | Venous thromboembolism | 14 Sep 2016 | Pharmathen |
Trazimera | trastuzumab | Stomach Neoplasms | 26 Jul 2018 | Pfizer |
Breast Neoplasms | ||||
Truxima | rituximab | Chronic lymphocytic leukaemia | 17-feb-17 | Celltrion |
Granulomatosis with polyangiitis | ||||
Microscopic polyangiitis | ||||
Non-Hodgkin’s lymphoma | ||||
Rheumatoid arthritis | ||||
Udenyca | pegfilgrastim | Neutropenia | 21 Sep 2018 | ERA Consulting (Coherus Biosciences) |
Yuflyma | adalimumab | Axial spondyoarthritis | CHMP positive opinion 10 Dec 2020 | Celltrion Healthcare |
Crohn’s Disease | ||||
Juvenile idiopathic arthritis | ||||
Hidradenitis suppurativa | ||||
Psoriatic arthritis | ||||
Psoriasis | ||||
Rheumatoid arthritis | ||||
Ulcerative colitis | ||||
Uveitis | ||||
Zarzio | filgrastim | Cancer | 06-feb-09 | Sandoz |
Haematopoietic stem cell transplantation | ||||
Neutropenia | ||||
Zercepac | trastuzumab | "Stomach Neoplasms | 27 Jul 2020 | Accord Healthcare |
Breast Neoplasms" | ||||
Zessly | infliximab | Ankylosing spondylitis | 18 May 2018 | Sandoz |
Crohn’s disease | ||||
Psoriatic arthritis | ||||
psoriasis | ||||
Rheumatoid arthritis | ||||
Ulcerative colitis | ||||
Ziextenzo | pegfilgrastim | Neutropenia | 22-nov-18 | Sandoz |
Zirabev | bevacizumab | Breast neoplasms | 14-feb-19 | Pfizer |
Colorectal neoplasms | ||||
Non-small-cell lung carcinoma | ||||
Renal cell carcinoma | ||||
Uterine cervical neoplasms | ||||
*Data updated on 12 February 2021. | ||||
CHMP: Committee for Medicinal Products for Human Use; IVF: in vitro fertilization. | ||||
Source: EMA. |