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.