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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   43871   clinical trials with a EudraCT protocol, of which   7290   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 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2019-003662-40 Sponsor Protocol Number: UKER-AMGEVITA-CED-NOVO-01 Start Date*: 2019-12-18
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic i...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10021972 Inflammatory bowel disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-002214-77 Sponsor Protocol Number: 1504-MAD-024-AR Start Date*: 2016-05-05
    Sponsor Name:IVI Madrid
    Full Title: Prospective randomized clinical trial to test the efficacy of a biosimilar recombinant FSH (Bemfola) vs. urinary FSH (Fostipur) in an oocyte donation program
    Medical condition: The proposed study is to determine the efficacy of a recombinant FSH biosimilar vs. urinary FSH in oocyte donation program
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-005175-78 Sponsor Protocol Number: SAMSON-II Start Date*: 2019-10-10
    Sponsor Name:Prestige BioPharma Limited
    Full Title: A Randomized, Double-blind, Parallel Group, Equivalence, Multicenter Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in patients with Metas...
    Medical condition: Non-squamous Non-small Cell Lung Cancer (nsNSCLC)
    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: SK (Ongoing) HU (Ongoing) GR (Ongoing) PL (Completed) BG (Completed) LV (Ongoing) HR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000717-37 Sponsor Protocol Number: AMGEVITA-HVM2019 Start Date*: 2019-06-27
    Sponsor Name:Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)
    Full Title: LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY. "ADA-SWITCH Study"
    Medical condition: Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-001954-14 Sponsor Protocol Number: 1 Start Date*: 2015-09-14
    Sponsor Name:Santeon
    Full Title: SIMILAR Trial: Santeon InflixMab biosimILAr Research A randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Inflix...
    Medical condition: ulcerative colitis and Crohn’s disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    19.0 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001546-33 Sponsor Protocol Number: RHMMED1526 Start Date*: 2018-07-11
    Sponsor Name:University Southampton Hospital NHS Foundation Trust
    Full Title: IBD Biosimilar to Biosimilar Infliximab Switching Study
    Medical condition: Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10021972 Inflammatory bowel disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002854-22 Sponsor Protocol Number: UGA2014-01 Start Date*: 2020-01-03
    Sponsor Name:Aryogen Pharmed
    Full Title: A RANDOMIZED, MULTICENTER, DOUBLE BLIND CLINICAL TRIAL COMPARING PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY OF A BIOSIMILAR EPTACOG ALFA (ARYOSEVEN) AND NOVOSEVEN®, IN PATIENTS WITH HAEMOPHILIA A ...
    Medical condition: HAEMOPHILIA A OR B WITH INHIBITORS
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053752 Hemophilia B with anti factor IX LLT
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adults Gender: Male
    Trial protocol: BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-004463-25 Sponsor Protocol Number: RHMMED1716 Start Date*: 2020-12-15
    Sponsor Name:University Hospital Southampton NHS Trust
    Full Title: SWitching InflixiMab to SUbcut from Intravenous Therapy
    Medical condition: Crohn's Disease Ulcerative Colitis Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-004967-30 Sponsor Protocol Number: RHMMED1596 Start Date*: 2019-04-30
    Sponsor Name:University Hospital Southampton NHS Foundation Trust
    Full Title: IBD Reference and Biosimilar adalimumab CroSS over Study
    Medical condition: Crohn’s disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-004861-29 Sponsor Protocol Number: Modic03 Start Date*: 2018-05-16
    Sponsor Name:FOU, Nevroklinikken, Oslo University Hospital -Ullevål
    Full Title: BackToBasic: The effect of Infliximab in patients with chronic low back pain and Modic changes. A randomized, double blind, placebo-controlled, multicenter trial
    Medical condition: Non-specific chronic low back pain of more than 6 months duration. We will only investigate those who have vertebral end-plate chanages(Modic changes) on MRI.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10008837 Chronic back pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001769-26 Sponsor Protocol Number: MB02-C-02-17 Start Date*: 2017-11-30
    Sponsor Name:mAbxience Research SL
    Full Title: STELLA – A Randomized, Multicenter, Multinational, Double-Blind Study to Assess the Efficacy and Safety of MB02 (Bevacizumab Biosimilar Drug) Versus Avastin® in Combination With Carboplatin and Pac...
    Medical condition: Stage IIIB/IV Non-squamous Non-Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000015833 10079440 Non-squamous non-small cell lung cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed) GR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-000412-29 Sponsor Protocol Number: 17-23987 Start Date*: 2019-10-18
    Sponsor Name:F.I. Proctor Foundation, University of California San Francisco
    Full Title: Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST)
    Medical condition: juvenile-idiopathic arthritis paediatric uveitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10022557 Intermediate uveitis LLT
    20.0 100000004853 10033687 Panuveitis LLT
    20.1 100000004862 10036370 Posterior uveitis LLT
    20.1 100000004853 10066681 Acute uveitis LLT
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10059176 Juvenile idiopathic arthritis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-004904-31 Sponsor Protocol Number: IFX4501 Start Date*: 2015-05-19
    Sponsor Name:Mundipharma Pharmaceuticals B.V.
    Full Title: An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s ...
    Medical condition: Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002857-31 Sponsor Protocol Number: SB12-3003 Start Date*: 2019-09-09
    Sponsor Name:Samsung Bioepis Co., Ltd.
    Full Title: A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity between SB12 (proposed eculizumab biosimilar) and Soliris® in Subjects ...
    Medical condition: Paroxysmal Nocturnal Haemoglobinuria
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-001088-26 Sponsor Protocol Number: MN42928 Start Date*: 2021-12-21
    Sponsor Name:F. HOFFMANN - LA ROCHE LTD.
    Full Title: SAKURABONSAI: CLINICAL, IMAGING AND BIOMARKER OPEN-LABEL STUDY IN NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) WITH SATRALIZUMAB AS AN INTERVENTION
    Medical condition: Neuromyelitis Optica Spectrum Disorder (NMOSD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10077875 Neuromyelitis optica spectrum disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) FR (Completed) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-000679-10 Sponsor Protocol Number: CAIN457K2340 Start Date*: 2017-11-16
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to as...
    Medical condition: Ankylosing spondylitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10002556 Ankylosing spondylitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Ongoing) FR (Completed) CZ (Completed) SK (Completed) FI (Completed) DK (Completed) NL (Completed) PT (Completed) PL (Completed) GR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-002061-54 Sponsor Protocol Number: Re-IMPROVE Start Date*: 2016-10-13
    Sponsor Name:UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI
    Full Title: "Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. Evaluatio...
    Medical condition: Rheumatoid arthritis, seronegative spondylo arthritis, Crohn's Disease, Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10002556 Ankylosing spondylitis PT
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    20.0 10017947 - Gastrointestinal disorders 10075634 Acute haemorrhagic ulcerative colitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-004357-86 Sponsor Protocol Number: GOIRC-05-2019 Start Date*: 2020-07-17
    Sponsor Name:GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
    Full Title: A Phase II open-label multicentreTrial of first-line Oxaliplatin-based chemotherapy combined with ABP 980 (Biosimilar Trastuzumab) in patients with advanced Gastric or gastro-Esophageal juncTion (G...
    Medical condition: HER2 positive advanced gastric or gastro-esophageal junction cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001150 Adenocarcinoma gastric PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-004172-35 Sponsor Protocol Number: SB3-G31-BC Start Date*: 2014-02-12
    Sponsor Name:Samsung Bioepis Co., Ltd.
    Full Title: A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Hercep...
    Medical condition: newly diagnosed primary HER2 positive early or locally advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072740 Locally advanced breast cancer LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) PL (Completed) BG (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2019-002041-38 Sponsor Protocol Number: SafE-OrBi Start Date*: 2019-07-29
    Sponsor Name:AZ Maria Middelares
    Full Title: Evaluation of the Safety and Effectiveness of switching from Originator (Humira®) to Biosimilar (Imraldi®) adalimumab in Flanders (SafE-OrBi)
    Medical condition: Inflammatory Bowel Diseases (Crohn's disease and Ulcerative Colitis)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10021184 IBD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
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