| Table 1: EMA approved biosimilars* |
| Product name | Active substance | Therapeutic area | Authorization date | Manufacturer/ Company name |
| Abasaglar (previously Abasria) | insulin glargine | Diabetes | 9 Sep 2014 | Eli Lilly/Boehringer Ingelheim |
| Abseamed | epoetin alfa | Anaemia Cancer Chronic kidney failure |
27 Aug 2007 | Medice Arzneimittel Pütter |
| Accofil | filgrastim | Neutropenia | 17 Sep 2014 | Accord Healthcare |
| Abevmy | bevacizumab | Breast cancer Carcinoma of the cervix Colon cancer Fallopian tube cancer Non-small-cell lung carcinoma Ovarian cancer Peritoneal cancer Renal cell cancer |
21 Apr 2021 | Mylan (now Viatris) |
| Alymsys | bevacizumab | Breast cancer Carcinoma of the cervix Colon cancer Fallopian tube cancer Non-small-cell lung carcinoma Ovarian cancer Peritoneal cancer Renal cell cancer |
26 Mar 2021 | mAbxience Research |
| Amgevita | adalimumab | Ankylosing spondylitis Crohn’s disease Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis |
21 Mar 2017 | Amgen |
| Amsparity | adalimumab | Ankylosing spondylitis Hidradenitis Suppurativa Crohn’s disease Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis Uvetis |
13 Feb 2020 | Pfizer |
| Aybintio | bevacizumab | Breast neoplasms Colorectal neoplasms Fallopian tube neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Peritoneal neoplasms Renal cell carcinoma Uterine cervical neoplasms |
19 Aug 2020 | Samsung Bioepis |
| Bemfola | follitropin alfa | Anovulation (IVF) | 26 Mar 2014 | Finox Biotech |
| Benepali | etanercept | Axial spondyloarthritis Psoriatic arthritis Plaque psoriasis Rheumatoid arthritis |
13 Jan 2016 | Samsung Bioepis |
| Binocrit | epoetin alfa | Anaemia Chronic kidney failure |
28 Aug 2007 | Sandoz |
| Blitzima | rituximab | Non-Hodgkin lymphoma Chronic B-cell lymphocytic leukaemia |
13 Jul 2017 | Celltrion |
| Byooviz | ranibizumab | Degenerative myopia Diabetic retinopathy Macular edema Wet macular degeneration |
18 Aug 2021 | Samsung Bioepis |
| Cegfila (previously Pegfilgrastim Mundipharma) | pegfilgrastim | Neutropenia | 19 Dec 2019 | Mundipharma Biologics |
| Enoxaparin BECAT | enoxaparin sodium | Venous thromboembolism | 24 Mar 2017 | Laboratorios ROVI |
| Epoetin alfa Hexal | epoetin alfa | Anaemia Cancer Chronic kidney failure |
27 Aug 2007 | Hexal |
| Erelzi | etanercept | Ankylosing spondylitis Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis |
23 Jun 2017 | Sandoz |
| Filgrastim Hexal | filgrastim | Cancer Haematopoietic stem cell transplantation Neutropenia |
6 Feb 2009 | Hexal |
| Flixabi | infliximab | Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
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) |
| Hefiya | adalimumab | Ankylosing spondylitis Hidradenitis suppurativa Juvenile rheumatoid arthritis Psoriasis Uveitis |
26 Jul 2018 | Sandoz |
| Herzuma | trastuzumab | Early breast cancer Metastatic breast cancer Metastatic gastric cancer |
8 Feb 2018 | Celltrion Healthcare |
| Hukyndra | adalimumab | Ankylosing spondylitis Crohn’s Disease Hidradenitis suppurativa Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative Colitis Uveitis |
15 Nov 2021 | Alvotech/Stada Artnimettel |
| Hulio | adalimumab | Ankylosing spondylitis Crohn’s Disease Hidradenitis suppurativa Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative Colitis Uveitis |
17 Sep 2018 | Mylan/Fujifilm Kyowa Kirin Biologics |
| Hyrimoz | adalimumab | Ankylosing spondylitis Crohn’s Disease Hidradenitis suppurativa Juvenile rheumatoid arthritis Papulosquamous skin disease Psoriatic arthritis Rheumatoid arthritis Ulcerative Colitis Uveitis |
26 Jul 2018 | Sandoz |
| Idacio | adalimumab | Ankylosing spondylitis Arthritis Crohn’s Disease Hidradenitis suppurativa Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis Uveitis |
2 Apr 2019 | Fresenius Kabi |
| Imraldi | adalimumab | Ankylosing spondylitis Arthritis Crohn’s Disease Hidradenitis suppurativa Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis Uveitis |
24 Aug 2017 | Samsung Bioepis |
| Inflectra | infliximab | Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
10 Sep 2013 | Hospira (Pfizer) |
| 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 Metastatic breast cancer Metastatic gastric cancer |
16 May 2018 | Amgen/Allergan |
| Kirsty (previously Kixelle) | insulin aspart | Diabetes mellitus | 5 February 2021 | Mylan (now Viatris)/ Biocon |
| Libmyris | adalimumab | Ankylosing spondylitis Crohn’s Disease Hidradenitis suppurativa Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative Colitis Uveitis |
12 Nov 2021 | Alvotech/Stada Artnimettel |
| Livogiva | teriparatide | Osteoporosis | 27 Aug 2020 | Theramex Ireland |
| Movymia | teriparatide | Osteoporosis | 11 Jan 2017 | Stada Arzneimittel |
| Mvasi | bevacizumab | Breast neoplasms Fallopian tube neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Peritoneal neoplasms Renal cell carcinoma |
15 Jan 2018 | Amgen |
| Nepexto | etanercept | Ankylosing spondylitis Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Spondylarthropathies |
25 May 2020 | Mylan |
| Nivestim | filgrastim | Cancer Haematopoietic stem cell transplantation Neutropenia |
7 Jun 2010 | Hospira (Pfizer) |
| Nyvepria | pegfilgrastim | Neutropenia | 18 Nov 2020 | Pfizer |
| Ogivri | trastuzumab | Early breast cancer Metastatic breast cancer Metastatic gastric cancer |
12 Dec 2018 | Biocon/Mylan |
| Omnitrope | somatropin | Pituitary dwarfism Prader-Willi syndrome Turner syndrome |
12 Apr 2006 | Sandoz |
| Onbevzi | bevacizumab | Breast neoplasms Colorectal neoplasms Fallopian tube neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Peritoneal neoplasms Renal cell carcinoma Uterine Cervical Neoplasms |
11 Jan 2021 | Samsung Bioepis |
| Ontruzant | trastuzumab | Early breast cancer Metastatic breast cancer Metastatic gastric cancer |
15 Nov 2017 | Samsung Bioepis |
| Oyavas | bevacizumab | Breast cancer Carcinoma of the cervix Colon cancer Fallopian tube cancer Non-small-cell lung carcinoma Ovarian cancer Peritoneal cancer Renal cell cancer |
26 Mar 2021 | Stada Arzneimittel |
| Ovaleap | follitropin alfa | Anovulation (IVF) | 27 Sep 2013 | Teva Pharma |
| Pelgraz | pegfilgrastim | Neutropenia | 21 Sep 2018 | Accord Healthcare |
| Pelmeg | pegfilgrastim | Neutropenia | 20 Nov 2018 | Cinfa Biotech/Mundipharma |
| Ratiograstim | filgrastim | Cancer Haematopoietic stem cell transplantation Neutropenia |
15 Sep 2008 | Ratiopharm |
| Remsima | infliximab | Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis |
10 Sep 2013 | Celltrion |
| Retacrit | epoetin zeta | Anaemia Autologous blood transfusion Cancer Chronic kidney failure |
18 Dec 2007 | Hospira (Pfizer) |
| Rixathon | rituximab | Chronic B-cell lymphocytic leukaemia Microscopic polyangiitis Non-Hodgkin Lymphoma Rheumatoid arthritis Wegener granulomatosis |
15 Jun 2017 | Sandoz |
| Riximyo | rituximab | Chronic B-cell lymphocytic leukaemia Microscopic polyangiitis Non-Hodgkin Lymphoma Rheumatoid arthritis Wegener granulomatosis |
15 Jun 2017 | Sandoz |
| Ruxience | rituximab | Chronic lymphocytic leukaemia Granulomatosis with polyangiitis Microscopic polyangiitis Non-Hodgkin Lymphoma Rheumatoid arthritis Pemphigus vulgaris |
1 Apr 2020 | Pfizer |
| Semglee | insulin glargine | Diabetes | 28 Mar 2018 | Mylan |
| Silapo | epoetin zeta | Anaemia Autologous blood transfusion Cancer Chronic kidney failure |
18 Dec 2007 | Stada Arzneimittel |
| Sondelbay | teriparatide | Osteoporosis | CHMP positive opinion 27 Jan 2022 | Accord Healthcare |
| Stimufend | pegfilgrastim | Neutropenia | CHMP positive opinion 27 Jan 2022 | Fresenius Kabi |
| Terrosa | teriparatide | Osteoporosis | 4 Jan 2017 | Gedeon Richter |
| Tevagrastim | filgrastim | Cancer Haematopoietic stem cell transplantation Neutropenia |
15 Sep 2008 | Teva Generics |
| Trazimera | trastuzumab | Stomach Neoplasms Breast Neoplasms |
26 Jul 2018 | Pfizer |
| Truxima | rituximab | Chronic lymphocytic leukaemia Granulomatosis with polyangiitis Microscopic polyangiitis Non-Hodgkin’s lymphoma Rheumatoid arthritis |
17 Feb 2017 | Celltrion Healthcare |
| Vegzelma | bevacizumab | Breast neoplasms Colorectal neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Renal cell carcinoma |
CHMP positive opinion 24 Jun 2022 | Celltrion Healthcare |
| Yuflyma | adalimumab | Axial spondyoarthritis Crohn’s Disease Juvenile idiopathic arthritis Hidradenitis suppurativa Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis Uveitis |
11 Feb 2021 | Celltrion Healthcare |
| Zarzio | filgrastim | Cancer Haematopoietic stem cell transplantation Neutropenia |
6 Feb 2009 | Sandoz |
| Zercepac | trastuzumab | Stomach Neoplasms Breast Neoplasms |
27 Jul 2020 | Accord Healthcare |
| Zessly | infliximab | Ankylosing spondylitis Crohn’s disease Psoriatic arthritis psoriasis Rheumatoid arthritis Ulcerative colitis |
18 May 2018 | Sandoz |
| Ziextenzo | pegfilgrastim | Neutropenia | 22 Nov 2018 | Sandoz |
| Zirabev | bevacizumab | Breast neoplasms Colorectal neoplasms Non-small-cell lung carcinoma Renal cell carcinoma Uterine cervical neoplasms |
14 Feb 2019 | Pfizer |
| *Data updated on 1 July 2022 CHMP: Committee for Medicinal Products for Human Use; VF: in vitro fertilization. Source: EMA |
