| Table 1: EMA approved biosimilars* |
| Product name | Active substance | Therapeutic area | Authorization date | Manufacturer/ Company name |
| Abasaglar (previously Abasria) | insulin glargine | Diabetes mellitus | 9 Sep 2014 | Eli Lilly/Boehringer Ingelheim |
| 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) |
| Abseamed | epoetin alfa | Anaemia Cancer Chronic kidney failure | 27 Aug 2007 | Medice Arzneimittel Pütter |
| Absimky | ustekinumab | Crohn’s disease Paediatric psoriatic arthritis Plaque psoriasis Psoriatic arthritis | 12 Dec 2024 | Accord Healthcare |
| Accofil | filgrastim | Neutropenia | 17 Sep 2014 | Accord Healthcare |
| Acvybra | denosumab | Bone loss Osteoporosis | 18 Sep 2025 | Reddy Holding |
| Afiveg | aflibercept | Diabetes complications Choroidal neovascularization Macular oedema Retinal vein occlusion Wet macular degeneration | 18 Aug 2025 | Stada Arzneimittel |
| Afqlir | aflibercept | Diabetic macular oedema (DME) Macular oedema following retinal vein occlusion (branch RVO or central RVO) Myopic choroidal neovascularisation (myopic CNV) Neovascular (wet) age-related macular degeneration (AMD) | 13 Nov 2024 | Sandoz |
| Ahzantive/ Baiama | aflibercept | Diabetic macular oedema (DME) Myopic choroidal neovascularisation (myopic CNV) Neovascular (wet) age-related macular degeneration (AMD) Visual impairment due to macular oedema secondary to retinal vein occlusion | 13 Jan 2025 | Formycon AG |
| 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 |
| Avtozma | tocilizumab | COVID-19 Cytokine release syndrome (CRS) Giant cell arteritis (GCA) Polyarticular juvenile idiopathic arthritis (pJIA) Rheumatoid arthritis Systemic juvenile idiopathic arthritis (sJIA) | 14 Feb 2025 | Celltrion Healthcare |
| Avzivi | bevacizumab | Carcinoma, non-small-cell lung Carcinoma, renal cell Colorectal neoplasms Fallopian tube neoplasms Ovarian neoplasms Peritoneal neoplasms Uterine cervical neoplasms | 26 Jul 2024 | Bio-Thera Solutions, marketed by Sandoz |
| Bekemv | eculizumab | Atypical haemolytic uraemic syndrome (aHUS) Paroxysmal nocturnal haemoglobinuria (PNH) | 24 Feb 2023 | Amgen |
| 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 |
| Bildyos | denosumab | Bone resorption Osteoporosis | 17 Sep 2025 | Henlius, marketed by Organon |
| Bilprevda | denosumab | Giant cell tumor of bone Neoplasms, bone tissue | 17 Sep 2025 | Henlius, marketed by Organon |
| 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 |
| Bomyntra | denosumab | Prevention of skeletal-related events in adult with advanced malignancies involving bone Giant cell tumour of bone | 17 Jul 2025 | Fresenius Kabi |
| Byooviz | ranibizumab | Degenerative myopia Diabetic retinopathy Macular oedema Wet macular degeneration | 18 Aug 2021 | Samsung Bioepis |
| Cegfila (previously Pegfilgrastim Mundipharma) | pegfilgrastim | Neutropenia | 19 Dec 2019 | Mundipharma Biologics |
| Conexxence | denosumab | Osteoporosis | 18 Jul 2025 | Fresenius Kabi |
| Dazublys | trastuzumab | metastatic and early breast cancer | 30 Jun 2025 | CuraTeQ Biologics |
| Degevma | denosumab | Giant cell tumour of bone Prevention of skeletal related events | 18 Sep 2025 | Teva Pharma |
| Denbrayce | denosumab | Giant cell tumour of bone Prevention of skeletal related events | 26 Jun 2025 | mAbxience Research |
| Denosumab Intas | denosumab | Bone loss Osteoporosis | 18 Sep 2025 | Intas |
| Denosumab BBL | denosumab | Bone loss Osteoporosis | CHMP positive opinion 25 Apr 2025 | Biosimilar Collaborations Ireland Ltd |
| Dyrupeg | pegfilgrastim | Neutropenia | 28 Mar 2025 | CuraTeQ Biologics |
| Eksunbi | ustekinumab | Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis Ulcerative colitis | 12 Sep 2024 | Samsung Bioepis |
| Eiyzey | aflibercept | Diabetes complications Choroidal neovascularization Macular oedema Retinal vein occlusion Wet macular degeneration | 14 Aug 2025 | Zakłady Farmaceutyczne Polpharma |
| Enoxaparin BECAT | enoxaparin sodium | Venous thromboembolism | 24 Mar 2017 | Laboratorios ROVI |
| Enwylma | denosumab | Giant cell tumour of bone Prevention of skeletal related events | 26 Jun 2025 | Zentiva |
| Epoetin alfa Hexal | epoetin alfa | Anaemia Cancer Chronic kidney failure | 27 Aug 2007 | Hexal |
| Epruvy (previously Ranibizumab Midas) | ranibizumab | Neovascular (wet) age-related macular degeneration (AMD) Visual impairment due to diabetic macular oedema (DME) Proliferative diabetic retinopathy (PDR) Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) Visual impairment due to choroidal neovascularisation (CNV) | 19 Sep 2024 | Midas Pharma GmbH (developed by Bioeq AG) |
| Epysqli | eculizumab | Atypical Hemolytic Uremic Syndrome (aHUS) Paroxysmal nocturnal hemoglobinuria: adult and children | 26 May 2023 22 Mar 2024 (for aHUS) | Samsung Bioepis |
| Erelzi | etanercept | Ankylosing spondylitis Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis | 23 Jun 2017 | Sandoz |
| Evfraxy, formerly denosumab BBL | denosumab | Bone loss Osteoporosis | 30 Jun 2025 | Biocon |
| Eydenzelt | aflibercept | Diabetic macular oedema (DME) Myopic choroidal neovascularisation (myopic CNV) Neovascular (wet) age-related macular degeneration (AMD) Visual impairment due to macular oedema secondary to retinal vein occlusion | 12 Feb 2025 | Celltrion Healthcare |
| Eyluxvi | aflibercept | Diabetes complications Macular oedema Retinal vein occlusion Wet macular degeneration | 15 Sep 2025 | Biolitec Pharma / Alteogen |
| 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 (now Viatris) |
| Fymskina | ustekinumab | Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis Ulcerative colitis | 25 Sep 2024 | Formycon AG |
| Gobivaz | golimumab | Ankylosing spondylitis Psoriatic arthritis Rheumatoid arthritis | 18 Sep 2025 | Alvotech/Advanz Pharma |
| Gotenfia | golimumab | Ankylosing spondylitis Psoriatic arthritis Rheumatoid arthritis | 10 Feb 2026 | Stada/Bio-Thera |
| 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 |
| Herwenda | trastuzumab | Early breast cancer Metastatic breast cancer Metastatic gastric cancer | 15 Nov 2023 | Sandoz |
| 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 |
| Imuldosa | ustekinumab | Crohn’s disease paediatric psoriatic arthritis plaque psoriasis psoriatic arthritis ulcerative colitis | 12 Dec 2024 | Accord Healthcare |
| 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 |
| Ituxredi | rituximab | Chronic lymphocytic leukaemia Granulomatosis with polyangiitis and microscopic polyangiitis Non-Hodgkin’s lymphoma Pemphigus vulgar Rheumatoid arthritis | 19 Sep 2024 | Reddy Holding |
| Izamby | denosumab | Bone loss Osteoporosis | 26 Jun 2025 | mAbxience Research |
| Jubereq, see also Osvyrti | denosumab | Bone tissue neoplasms Giant cell tumour of bone | 26 May 2025 | Accord Healthcare |
| Jubbonti | denosumab | Bone resorption Osteoporosis Postmenopausal osteoporosis | 16 May 2024 | Sandoz |
| Junod | denosumab | Bone loss Osteoporosis | 23 Jun 2025 | Gedeon Richter |
| Kanjinti | trastuzumab | Early breast cancer Metastatic breast cancer Metastatic gastric cancer | 16 May 2018 | Amgen/Allergan |
| Kefdensis | denosumab | Bone loss Osteoporosis | 18 Sep 2025 | Alvotech/Stada Artnimettel |
| Kirsty (previously Kixelle) | insulin aspart | Diabetes mellitus | 5 February 2021 | Biocon/Viatris (formerly Mylan) |
| 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 |
| Mynzepli | aflibercept | Diabetes complications Choroidal neovascularization Macular oedema Retinal vein occlusion Wet macular degeneration | 18 Aug 2025 | Advanz Pharma |
| Nepexto | etanercept | Ankylosing spondylitis Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Spondylarthropathies | 25 May 2020 | Mylan (now Viatris) |
| Nivestim | filgrastim | Cancer Haematopoietic stem cell transplantation Neutropenia | 7 Jun 2010 | Hospira (Pfizer) |
| Nyvepria | pegfilgrastim | Neutropenia | 18 Nov 2020 | Pfizer |
| Obodence | denosumab | Bone resorption Osteoporosis Postmenopausal osteoporosis | 12 Feb 2025 | Samsung Bioepis |
| Ogivri | trastuzumab | Early breast cancer Metastatic breast cancer Metastatic gastric cancer | 12 Dec 2018 | Biocon/Mylan |
| Omlyclo | omalizumab | Asthma Urticaria | 23 May 2024 | Celltrion Healthcare |
| 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 |
| Ondibta | insulin glargine | Diabetes | 13 Dec 2025 | Gan & Lee |
| Ontruzant | trastuzumab | Early breast cancer Metastatic breast cancer Metastatic gastric cancer | 15 Nov 2017 | Samsung Bioepis |
| Opuviz | aflibercept | Diabetic macular oedema (DME) Macular oedema following retinal vein occlusion (branch RVO or central RVO) Myopic choroidal neovascularisation (myopic CNV) Neovascular (wet) age-related macular degeneration (AMD) | 13 Nov 2024 | Samsung Bioepis |
| Osenvelt | denosumab | Giant cell tumor of bone Neoplasms, Bone tissue | 14 Feb 2025 | Celltrion Healthcare |
| Osqay | denosumab | Bone resorption Osteoporosis Postmenopausal osteoporosis | 13 Dec 2025 | Theramax UK |
| Osvyrti, see also Jubereq | denosumab | Bone resorption Osteoporosis Postmenopausal osteoporosis | 26 May 2025 | Accord Healthcare |
| Otulfi | ustekinumab | Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis Ulcerative colitis | 25 Sep 2024 | Fresenius Kabi |
| 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 |
| Pavblu | aflibercept | Choroidal neovascularization Diabetes complications Macular oedema Retinal vein occlusion Wet macular degeneration | 10 April 2025 | Amgen |
| Pelgraz | pegfilgrastim | Neutropenia | 21 Sep 2018 | Accord Healthcare |
| Pelmeg | pegfilgrastim | Neutropenia | 20 Nov 2018 | Cinfa Biotech/Mundipharma |
| Ponlimsi | denosumab | Bone loss Osteoporosis | 18 Sep 2025 | Teva Pharma |
| Pyzchiva | ustekinumab | Crohn’s disease Paediatric plaque psoriasis Psoriatic arthritis Ulcerative colitis | 22 Apr 2024 | Samsung Bioepis |
| Qoyvolma | ustekinumab | Crohn’s disease Paediatric plaque psoriasis Psoriatic arthritis Ulcerative colitis | 2 Jun 2025 | Celltrion Healthcare |
| 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 |
| Ranivisio | ranibizumab | Diabetes complications Diabetic retinopathy Macular oedema Wet macular degeneration | 25 Aug 2022 | Bioeq/Teva Pharma |
| Ranluspec | ranibizumab | Choroidal neovascularization Diabetes complications Diabetic retinopathy Macular oedema Retinal vein occlusion Wet macular degeneration | 10 Feb 2026 | Lupin |
| Retacrit | epoetin zeta | Anaemia Autologous blood transfusion Cancer Chronic kidney failure | 18 Dec 2007 | Hospira (Pfizer) |
| Rimmyrah | ranibizumab | Neovascular (wet) age-related macular degeneration (AMD) Visual impairment due to diabetic macular oedema (DME) Proliferative diabetic retinopathy (PDR) Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) Visual impairment due to choroidal neovascularisation (CNV) | 5 Jan 2024 | Qilu Pharma |
| Rixathon | rituximab | Chronic B-cell ly+C85mphocytic 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 |
| Rolcya | denosumab | Bone loss Osteoporosis | 17 Jul 2025 | 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 mellitus | 28 Mar 2018 | Biocon/Viatris (formerly Mylan) |
| Silapo | epoetin zeta | Anaemia Autologous blood transfusion Cancer Chronic kidney failure | 18 Dec 2007 | Stada Arzneimittel |
| Sondelbay | teriparatide | Osteoporosis | 24 Mar 2022 | Accord Healthcare |
| Steqeyma | ustekinumab | Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis | 22 Aug 2024 | Celltrion Healthcare |
| Stimufend | pegfilgrastim | Neutropenia | 24 Mar 2022 | Fresenius Kabi |
| Stoboclo | denosumab | Bone resorption Osteoporosis Postmenopausal osteoporosis | 14 Feb 2025 | Celltrion Healthcare |
| Terrosa | teriparatide | Osteoporosis | 4 Jan 2017 | Gedeon Richter |
| Tevagrastim | filgrastim | Cancer Haematopoietic stem cell transplantation Neutropenia | 15 Sep 2008 | Teva Pharma |
| Tofidence | tocilizumab | Polyarticular juvenile idiopathic arthritis Rheumatoid arthritis Systemic juvenile idiopathic arthritis | 20 Jun 2024 | Biogen |
| Trazimera | trastuzumab | Stomach Neoplasms Breast Neoplasms | 26 Jul 2018 | Pfizer |
| Truvelog Mix 30 | insulin aspart | Diabetes mellitus | Apr 2022 | Sanofi-Aventis |
| Truxima | rituximab | Chronic lymphocytic leukaemia Granulomatosis with polyangiitis Microscopic polyangiitis Non-Hodgkin’s lymphoma Rheumatoid arthritis | 17 Feb 2017 | Celltrion Healthcare |
| Tuznue | trastuzumab | Breast cancer Metastatic gastric cancer | 19 Sep 2024 | Prestige Biopharma Belgium BVBA |
| Tyenne | tocilizumab | Active systemic juvenile idiopathic arthritis Chimeric antigen receptor T cell-induced cytokine release syndrome COVID-19 Giant cell arteritis Juvenile idiopathic polyarthritis | 15 Sep 2023 | Fresenius Kabi |
| Tyruko | natalizumab | Multiple sclerosis Relapsing-remitting multiple sclerosis | 26 Sep 2023 | Sandoz |
| Usgena | ustekinumab | Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis (PsA) | 18 Sep 2025 | Bio-Thera/Stada |
| Usrenty | ustekinumab | Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis (PsA) Ulcerative colitis | 17 Sep 2025 | Biosimilar Collaborations Ireland |
| Usymro | ustekinumab | Crohn’s disease Paediatric plaque psoriasis Psoriasis Psoriatic arthritis (PsA) | 14 Aug 2025 | ELC Group |
| Uzpruvo | ustekinumab | Crohn’s disease Paediatric plaque psoriasis Psoriasis Psoriatic arthritis (PsA) | 5 Jan 2024 | Alvotech/Stada Arzneimittel |
| Vegzelma | bevacizumab | Breast neoplasms Colorectal neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Renal cell carcinoma | 17 Aug 2022 | Celltrion Healthcare |
| Vevzuo | denosumab | Giant cell tumour of bone Prevention of skeletal related events | 25 Jun 2025 | Biocon |
| Vgenfli | aflibercept | Diabetes complications Choroidal neovascularization Macular oedema Retinal vein occlusion Wet macular degeneration | 14 Aug 2025 | Zakłady Farmaceutyczne Polpharma |
| Vivlipeg | pegfilgrastim | Neutropenia | 18 Aug 2025 | Biosimilar Collaborations Ireland |
| Wezenla | ustekinumab | Crohn’s disease Plaque psoriasis, including paediatric plaque psoriasis Psoriatic arthritis | 20 Jun 2024 | Amgen |
| Wyost | denosumab | Giant cell tumor of bone Neoplasms, Bone tissue | 16 May 2024 | Sandoz |
| Xbonzy | denosumab | Giant cell tumour of bone Prevention of skeletal related events | 18 Sep 2025 | Reddy Holding |
| Ximluci | ranibizumab | Diabetes complications Diabetic retinopathy Macular oedema Wet macular degeneration | 9 Nov 2022 | Stada Arzneimittel/Xbrane Biopharma |
| Xbryk | denosumab | Giant cell tumor of bone Neoplasms, Bone tissue | 12 Feb 2025 | Samsung Bioepis |
| Yaxwer | denosumab | Giant cell tumour of bone Prevention of skeletal related events | 23 Jun 2025 | Gedeon Richter |
| Yesafili | aflibercept | Degenerative diabetes complications Diabetic retinopathy myopia Macular oedema Retinal vein occlusion | 15 Sep 2023 | Biocon/Viatris (formerly Mylan) |
| Yesintek | ustekinumab | Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis (PsA) | 14 Feb 2025 | Biocon |
| 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 |
| Zadenvi | denosumab | Bone loss Osteoporosis | 26 Jun 2025 | Zentiva |
| Zandoriah | teriparatide | Osteoporosis | CHMP positive opinion 26 Feb 2026 | CinnaGen |
| Zarzio | filgrastim | Cancer Haematopoietic stem cell transplantation Neutropenia | 6 Feb 2009 | Sandoz |
| Zefylti | filgrastim | Cancer Haematopoietic stem cell transplantation Neutropenia | 12 Feb 2025 | CuraTeQ Biologics (Aurobindo) |
| 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 |
| Zvogra | denosumab | Giant cell tumour of bone Prevention of skeletal related events | 18 Sep 2025 | Stada Arzneimittel |
| *Data updated on 23 March 2026 CHMP: Committee for Medicinal Products for Human Use; IVF: in vitro fertilization. Source: EMA |