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Clinical trials for biosimilar

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44344   clinical trials with a EudraCT protocol, of which   7373   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    137 result(s) found for: biosimilar. Displaying page 5 of 7.
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    EudraCT Number: 2020-002701-26 Sponsor Protocol Number: 64304500CRD2002 Start Date*: 2021-01-12
    Sponsor Name:JANSSEN CILAG INTERNATIONAL NV
    Full Title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standa...
    Medical condition: Active Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-005506-56 Sponsor Protocol Number: MabionCD20-002NHL Start Date*: 2014-11-20
    Sponsor Name:MABION S.A.
    Full Title: Randomized, Parallel-group, Double-blind, Comparative Bioequivalence Trial of MabionCD20 (Mabion SA) Compared to MabThera (rituximab by Hoffman-La Roche) in Patients with Diffuse Large B-cell Lymphoma
    Medical condition: CD20 positive Diffuse Large B cell Lymphoma (DLBCL) patients diagnosed according to WHO classification of lymphomas, eligible for rituximab treatment according to MabThera SmPC with life expectance...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2021-000006-16 Sponsor Protocol Number: APHP201098 Start Date*: 2022-01-10
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: A phase 3 randomized and double-blind controlled trial comparing the efficacy and safety of subcutaneous belimumab or placebo in addition to rituximab in adult patients with persistent or chronic i...
    Medical condition: Adults with a definite diagnosis of primary chronic immune thrombocytopeniaaccording to the standard definition. Patients with antinuclear antibodies with no definite criteria for systemic lupus wi...
    Disease: Version SOC Term Classification Code Term Level
    23.0 10005329 - Blood and lymphatic system disorders 10083842 Immune thrombocytopenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000952-36 Sponsor Protocol Number: CT-P39_3.1 Start Date*: 2021-02-05
    Sponsor Name:CELLTRION, Inc.
    Full Title: A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients With Chronic Spontaneous Urticaria Who Remain Symptomati...
    Medical condition: Chronic Spontaneous Urticaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10072757 Chronic spontaneous urticaria PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2015-004614-26 Sponsor Protocol Number: ONS-3010-002 Start Date*: 2016-07-25
    Sponsor Name:Oncobiologics Limited
    Full Title: A Randomized, Double-Blind, Multicenter, Equivalence Study of ONS-3010 and Humira® for the Treatment of Patients with Moderate to Severe Plaque Psoriasis
    Medical condition: Moderate to Severe Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) PL (Completed) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-005368-13 Sponsor Protocol Number: AGB001 Start Date*: 2016-11-22
    Sponsor Name:Archigen Biotech Limited
    Full Title: A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rh...
    Medical condition: Severe Rheumatoid Arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10039075 Rheumatoid arthritis and associated conditions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) ES (Completed) CZ (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-002949-30 Sponsor Protocol Number: ATA129-EBV-302 Start Date*: 2020-07-17
    Sponsor Name:Atara Biotherapeutics, Inc.
    Full Title: Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative D...
    Medical condition: Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068349 Epstein-Barr virus associated lymphoproliferative disorder PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075146 Post transplant Epstein-Barr virus associated lymphoproliferative disorder LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Trial now transitioned) ES (Ongoing) AT (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-005543-90 Sponsor Protocol Number: 20130108 Start Date*: 2014-08-26
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) PL (Completed) BG (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002147-28 Sponsor Protocol Number: CT-P16_3.1 Start Date*: 2018-12-10
    Sponsor Name:CELLTRION, Inc.
    Full Title: A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non...
    Medical condition: Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10079440 Non-squamous non-small cell lung cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) HU (Completed) BG (Completed) PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2013-000738-36 Sponsor Protocol Number: 20120265 Start Date*: 2013-10-15
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety OF ABP 215 Compared with Bevacizumab in Subjects with Advanced Non-Small Cell Lung Cancer
    Medical condition: Advanced Non-small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) DE (Completed) IT (Completed) ES (Completed) NL (Completed) GR (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-000828-15 Sponsor Protocol Number: I4L-MC-ABEC Start Date*: 2011-09-08
    Sponsor Name:Eli Lilly and Company
    Full Title: A Prospective, Randomized, Double-Blind Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus® in Adult Patients with Type 2 Diabetes Mellitus
    Medical condition: type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    13.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) GR (Completed) PL (Completed) HU (Completed) DE (Completed) SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000132-41 Sponsor Protocol Number: B3281006 Start Date*: 2014-10-10
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA
    Medical condition: low tumor burden follicular lymphoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) ES (Completed) IT (Completed) PT (Completed) AT (Completed) HR (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2013-005542-11 Sponsor Protocol Number: 20130109 Start Date*: 2014-10-14
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared with Rituximab in Subjects with CD20 Positive B-Cell Non-Hodgkin Lymphoma (NHL)
    Medical condition: CD20 positive B-cell non-Hodgkin lymphoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) RO (Completed) IT (Completed) ES (Completed) FR (Completed) BG (Completed) PL (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2014-003878-16 Sponsor Protocol Number: B7391003 Start Date*: 2015-05-27
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: A Phase 3 randomized, double-blind study of PF-06439535 plus Paclitaxel-Carboplatin and Bevacizumab plus Paclitaxel-Carboplatin for the first-line treatment of patients with advanced non-squamous n...
    Medical condition: Advanced non-squamous non-small cell lung cancer.
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) NL (Completed) CZ (Completed) DE (Completed) ES (Completed) PL (Completed) HU (Completed) GR (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001796-17 Sponsor Protocol Number: TV45779-IMB-30086 Start Date*: 2021-11-30
    Sponsor Name:Teva Pharmaceuticals, Inc.
    Full Title: A Multinational, Multicenter, Randomized, Double Blind Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of TEV-45779 Compared to Omalizum...
    Medical condition: Chronic Idiopathic Urticaria/Chronic Spontaneous Urticaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10020197 Hives LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) CZ (Completed) PL (Completed) GR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2014-004704-29 Sponsor Protocol Number: 20140111 Start Date*: 2016-12-15
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) HU (Completed) DE (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-002801-20 Sponsor Protocol Number: NN1250-4252 Start Date*: 2017-02-10
    Sponsor Name:Novo Nordisk A/S
    Full Title: A trial comparing the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without ora...
    Medical condition: Diabetes Mellitus, Type 2
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) DK (Completed) EE (Completed) GR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-004369-42 Sponsor Protocol Number: FKS456-001 Start Date*: 2020-04-27
    Sponsor Name:Fresenius Kabi SwissBioSim GmbH
    Full Title: A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients w...
    Medical condition: Moderately to severely active Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) PL (Completed) BG (Completed) CZ (Completed) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-011483-11 Sponsor Protocol Number: NMDSG08A Start Date*: 2009-11-18
    Sponsor Name:NMDSG
    Full Title: Clinical and biological evaluation of azacitidine in transfusion-dependent patients with Low and intermediate-1 risk MDS, and low-risk CMML, who are either refractory to or not eligible for treatme...
    Medical condition: Low and intermediate-1 risk MDS, and low-risk CMML.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10009018 Chronic myelomonocytic leukaemia LLT
    12.0 10028533 Myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000525-31 Sponsor Protocol Number: 20120262 Start Date*: 2013-08-27
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis
    Medical condition: Moderate to Severe Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    16.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) ES (Completed) DE (Completed) HU (Completed) PL (Completed) BG (Completed) RO (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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