- |||||||||| Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm
Enrollment open: RI-01-007: A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products (clinicaltrials.gov) - May 27, 2020 P3, N=140, Recruiting, In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Not yet recruiting --> Recruiting
- |||||||||| Reditux (rituximab biosimilar) / Dr. Reddy’s, Abbott, EMD Serono, CinnaGen, doxorubicin hydrochloride / Generic mfg., cyclophosphamide intravenous / Generic mfg.
Clinical, PK/PD data, Journal: Randomized, Double-Blind, Pharmacokinetic Equivalence Trial Comparing DRL-Rituximab With MabThera in Patients With Diffuse Large B-Cell Lymphoma. (Pubmed Central) - May 23, 2020 Not yet recruiting --> Recruiting DRL_RI and RMP had equivalent PKs, with comparable efficacy, PDs, safety, and immunogenicity.
- |||||||||| Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm
Trial initiation date: RI-01-007: A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products (clinicaltrials.gov) - Apr 8, 2020 P3, N=140, Not yet recruiting, Prospective randomized clinical trials are needed to determine the efficacy and safety profile of Redditux®. Initiation date: Feb 2020 --> May 2020
- |||||||||| Reditux (rituximab biosimilar) / Dr. Reddy’s, Abbott, EMD Serono, CinnaGen
Retrospective data, Journal: Comparison of the Efficacy of Innovator Rituximab and its Biosimilars in Diffuse Large B Cell Lymphoma Patients: A Retrospective Analysis. (Pubmed Central) - Mar 17, 2020 In this single center, retrospective, observational study, we have compared patient outcomes such complete response (CR), partial response (PR), and overall response rate (ORR) in a cohort of 152 patients in an Indian hospital, who were treated either with innovator rituximab or Reditux, a biosimilar...The differences in the 3-year event-free survival and overall survival were not statistically significant. Biosimilar rituximab can suitably and safely replace the innovator rituximab for treatment of diffuse large B cell lymphoma.
- |||||||||| Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm
New P3 trial: FLINTER: Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera (clinicaltrials.gov) - Jun 4, 2019 P3, N=284, Recruiting,
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, cetuximab biosimilar / CinnaGen
Trial completion date, Trial primary completion date, Metastases: Comparing Efficacy and Safety of Cetuximab (CinnaGen) Versus Erbitux (clinicaltrials.gov) - Feb 14, 2018 P3, N=234, Recruiting, Initiation date: Apr 2017 --> Oct 2016 Trial primary completion date: Feb 2018 --> Nov 2019 | Trial completion date: Nov 2018 --> Feb 2020
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, cetuximab biosimilar / CinnaGen
Enrollment open, Metastases: Comparing Efficacy and Safety of Cetuximab (CinnaGen) Versus Erbitux (clinicaltrials.gov) - Jan 30, 2018 P3, N=234, Recruiting, Trial primary completion date: Feb 2018 --> Nov 2019 | Trial completion date: Nov 2018 --> Feb 2020 Not yet recruiting --> Recruiting
- |||||||||| Reditux (rituximab biosimilar) / Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
New P2/3 trial, Adverse events: Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients (clinicaltrials.gov) - Dec 23, 2016 P2/3, N=76, Completed,
- |||||||||| Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Enrollment open, Trial primary completion date: Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - Jul 14, 2016 P2, N=40, Recruiting, Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2021 --> Mar 2021
- |||||||||| Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
New P2 trial: Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - Jan 21, 2016 P2, N=40, Not yet recruiting,
|