| 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. | ||||
