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