biosimilar Clinical Research Trials

Study Investigating PK PD Efficacy Safety and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

This is a multicenter, randomized, parallel arm, double-blind study with a total duration up to 82 weeks. Approximately 522 postmenopausal patients with osteoporosis will be randomized at the beginning of Treatment Period 1 (Baseline to Week 52) to receive 2 doses of either GP2411 or EU-authorized Prolia. At the beginning …

441 views
16 Sep, 2020
52 locations

Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO and EPREX in terms of 52-week comparisons in efficacy, safety and immunogenicity. The targeted population is anaemia patients with end-stage chronic renal disease who previously received epoetin treatment and on haemodialysis.

dialysis

erythropoietin

eprex

chronic kidney disease

biosimilar

96 views
29 Oct, 2020
19 locations

Clinical Trial Comparing a Biosimilar Eptacog Alfa With Novoseven in Patients With Hemophilia With Inhibitors

biosimilar eptacog alfa (activated) with Novoseven in 48 patients, adult and children (>12 years), not bleeding, with hemophilia A or B with inhibitors. Patients will be randomized to receive either a

18 views
15 Jan, 2021
13 locations

Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven in Patients With Congenital Factor VII Deficiency

The purpose of this multicentre, randomized, double blinded, single dose, two-way cross-over study, is to compare the pharmacokinetics (PK) of biosimilar eptacog alfa (activated) with Novoseven

12 views
15 Jan, 2021
2 locations

A Double-blind Study to Compare the Efficacy Safety and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara in Patients With Moderate-to-Severe Plaque Psoriasis

This is a randomized, double-blind, multicenter study to evaluate the efficacy, safety, and immunogenicity of FYB202 compared to Stelara in patients with Moderate-to-Severe Plaque Psoriasis.

0 views
26 Oct, 2020
2 locations

A Phase 1 Study to Assess the Immunogenicity of QL0605 Compared to US Neulasta in Healthy Subjects

Pharmaceutical Co., Ltd. proposed biosimilar QL0605 compared to innovator product, US-Neulasta) in healthy, adult, human subjects.

0 views
11 Dec, 2020
2 locations

A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1)

combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50.

trastuzumab

estrogen

progesterone receptor

progesterone

primary tumor

89 views
09 Sep, 2020
15 locations

Extension Study of MYL-1701P-3001 for Safety and Efficacy

This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 study.

0 views
26 Dec, 2020
1 location

PK Bioequivalence Single-dose Safety Tolerability Study in Healthy Male Volunteers to Compare CBT124 & Avastin(EU&US)

This study aims to investigate the bioequivalence of new formulation of bevacizumab called CBT124 and safety when compared to two already marketed formulations, one approved in US and other in EU of Avastin(Registered Trademark). Adult healthy male aged 18 to 50 years (both inclusive) can participate in this trial. Participants …

0 views
08 Nov, 2020
1 location

Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis in Patients With nAMD

The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).

age-related macular degeneration

vegf

angiography

ranibizumab

corrected visual acuity

249 views
08 Jul, 2020
109 locations

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Found 46 clinical trials