 |
2 Diseases |  |
0 Trials |
|
0 Trials |  |
67 News |  |
- | Rituxan (rituximab) / Roche
Journal: Occlusive Vasculitis Following Intravitreal Rituximab Injection for Primary Vitreoretinal Lymphoma. (Pubmed Central) - Jun 24, 2024
Occlusive vasculitis is a rarely reported but potential complication of intravitreal rituximab therapy in patients who have been previously treated with the agent and may have delayed onset. A low threshold for fluorescein angiography as a diagnostic test for post-injection vision loss and prompt treatment with topical and/or oral steroids should be considered.
- Truxima (rituximab-abbs) / Indukern, Teva, Mundipharma, Celltrion, Nippon Kayaku, Riabni (rituximab-arrx) / Amgen, AbbVie
Uptake and Costs of Rituximab Biosimilars Among the Medicare and Medicaid Populations in 2019-2021 in the United States () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_510;
A low threshold for fluorescein angiography as a diagnostic test for post-injection vision loss and prompt treatment with topical and/or oral steroids should be considered. This exploratory study evaluated the uptake and costs of three biosimilars rituximab-abbs (Truxima
- | Truxima (rituximab-abbs) / Indukern, Teva, Mundipharma, Celltrion, Nippon Kayaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Journal: Rituximab reference vs biosimilar utilization for oncology vs nononcology indications. (Pubmed Central) - Nov 14, 2023
This exploratory study evaluated the uptake and costs of three biosimilars rituximab-abbs (Truxima Real-world evidence shows an increase in rituximab biosimilar adoption over time, with higher adoption for oncology vs nononcology indications and in nonacademic settings.
- | Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab, Briumvi (ublituximab) / TG Therap, Mavenclad (cladribine) / EMD Serono
Journal: Ublituximab (Briumvi) for relapsing multiple sclerosis. (Pubmed Central) - Mar 7, 2023
Real-world evidence shows an increase in rituximab biosimilar adoption over time, with higher adoption for oncology vs nononcology indications and in nonacademic settings. No abstract available
- Truxima (rituximab-abbs) / Teva, Mundipharma, Celltrion, Nippon Kayaku, Indukern, Servier, Riabni (rituximab-arrx) / Amgen, AbbVie
Comparison of Adverse Event Profiles of Rituximab, Rituximab Hycela and Rituximab Biosimilars: A Real-World Pharmacovigilance Database Analysis () - Nov 29, 2022 - Abstract #ASH2022ASH_8044;
Additional reporting on Rituximab-pvvr and Rituximab-arrx should also exhibit lower reaction rates as compared to Rituximab. Large scale clinical trials are necessary to establish if there is a real difference in ADR rates between different rituximab products.
- |||| Riabni (rituximab-arrx) / Amgen, AbbVie
FDA event: CORRECTION: Riabni is ALSO FDA approved for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis since Dec 2020 (Twitter) - Jun 13, 2022
- || Riabni (rituximab-arrx) / Amgen, AbbVie, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: A review of the totality of evidence in the development of ABP 798, a rituximab biosimilar. (Pubmed Central) - Jun 9, 2022
Comparative clinical efficacy and safety of ABP 798 with rituximab RP was demonstrated as a final step in patients with non-Hodgkin lymphoma and in those with rheumatoid arthritis. Overall, the totality of evidence supported the conclusion that ABP 798 is highly similar to rituximab RP and provided scientific justification for extrapolation to other approved indications of rituximab RP.
- |||||| Riabni (rituximab-arrx) / Amgen, AbbVie
FDA event, Orphan drug: FDA approved another rituximab biosimilar, rituximab-arrx (Riabni) (from Amgen), for use w/ MTX in active RA. Riabni is not currently approved for B-cell NHL, B-cell leukemia, MPA, or GPA. or pemphigus vulgaris (RTX is an orphan drug) https://t.co/Htk0xBx63X (Twitter) - Jun 8, 2022
- | Journal: Expanded Table: Some biologic drugs and JAK inhibitors for rheumatoid arthritis. (Pubmed Central) - Feb 8, 2022
Overall, the totality of evidence supported the conclusion that ABP 798 is highly similar to rituximab RP and provided scientific justification for extrapolation to other approved indications of rituximab RP. No abstract available
- || Riabni (rituximab-arrx) / Amgen, AbbVie, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal: Non-clinical similarity of biosimilar ABP 798 with rituximab reference product. (Pubmed Central) - Nov 25, 2021
Additionally, in vitro synergy of ABP 798 or RP with chemotherapeutic agents, in vivo xenograft studies in mice, and toxicological assessments in cynomolgus monkeys (including B cell depletion and toxicokinetics) were also conducted. Results from these non-clinical assessments contribute to the TOE supporting the biosimilarity between ABP 798 and rituximab RP across a range of primary and secondary MOAs and support justification for extrapolation to all indications of use for ABP 798 for which the RP is approved.
- || Riabni (rituximab-arrx) / Amgen, AbbVie, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal: Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product. (Pubmed Central) - Nov 4, 2021
P3
Results from these non-clinical assessments contribute to the TOE supporting the biosimilarity between ABP 798 and rituximab RP across a range of primary and secondary MOAs and support justification for extrapolation to all indications of use for ABP 798 for which the RP is approved. These results support a conclusion of similar clinical efficacy between ABP 798 and rituximab RP in patients with follicular lymphoma.
- || Riabni (rituximab-arrx) / Amgen, AbbVie, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, PK/PD data, Journal: A Randomized, Double-Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis. (Pubmed Central) - Sep 29, 2021
Complete CD19+ B-cell depletion on day 3 among groups confirmed PD similarity. These findings demonstrated PK/PD similarity between ABP 798 and rituximab RP in subjects with moderate to severe RA.
- | Riabni (rituximab-arrx) / Amgen, AbbVie, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product. (Pubmed Central) - Sep 1, 2021
The results of the analytical and functional similarity assessment demonstrate that ABP 798 is highly analytically similar to rituximab RP. These results support the totality of evidence and the scientific justification for extrapolation of ABP 798 to all therapeutic indications approved for rituximab.
- | Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab, Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Journal: Drugs for multiple sclerosis. (Pubmed Central) - May 25, 2021
These results support the totality of evidence and the scientific justification for extrapolation of ABP 798 to all therapeutic indications approved for rituximab. No abstract available
- || Riabni (rituximab-arrx) / Amgen, AbbVie, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal: Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis. (Pubmed Central) - May 15, 2021
• The safety and immunogenicity profiles for ABP 798 were similar to those for the rituximab RP. • The single transition from rituximab RP to ABP 798 did not show differences in efficacy, safety, or immunogenicity.
- Riabni (rituximab-arrx) / Amgen, AbbVie
[VIRTUAL] Biosimilar Candidate ABP 798: Additional Analyses from the Comparative Clinical Study () - Feb 21, 2021 - Abstract #CRAAHPA2021CRA-AHPA_205;
• The single transition from rituximab RP to ABP 798 did not show differences in efficacy, safety, or immunogenicity. These data further support that ABP 798 is similar to rituximab RP in PD, efficacy and safety.
- ABP 798 (rituximab biosimilar) / Amgen, AbbVie
[VIRTUAL] Totality of Scientific Evidence in the Development of ABP 798, a Biosimilar to Rituximab () - Nov 5, 2020 - Abstract #ASH2020ASH_5470;
The sensitivity analysis of ORR using local assessments in the NHL comparative clinical study was consistent with results from the primary efficacy analysis; the maximum percent reduction in index nodal lesions was similar for central and local assessments of disease. These results further support that ABP 798 is similar to the RP across a range of efficacy evaluations as well as primary and secondary mechanisms of action and add additional supporting data to the TOE.
- ABP 798 (rituximab biosimilar) / Amgen, AbbVie
[VIRTUAL] EFFICACY AND SAFETY OF ABP 798 COMPARED WITH RITUXIMAB: RESULTS FROM THE COMPARATIVE CLINICAL STUDY IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA () - May 16, 2020 - Abstract #EHA2020EHA_2291;
Conclusion Results of this study demonstrated clinical similarity between ABP 798 and rituximab RP in subjects with CD20-positive NHL †At the time of this submission, ABP 798 had not been approved by the FDA or any relevant regulatory agency and the indications are yet undetermined. Please consult ABP 798’s later approved label in the relevant country for information regarding the approved uses for ABP 798.
- ABP 798 (rituximab biosimilar) / Amgen, AbbVie
[VIRTUAL] Efficacy and safety of ABP 798 compared with rituximab: Results from the comparative clinical study in patients with non-Hodgkin’s. (Poster Board 377) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2164;
*At the time of this submission, ABP 798 had not been approved by the FDA or any relevant regulatory agency and the indications are yet undetermined. Please consult ABP 798’s later approved label in the relevant country for information regarding the approved uses for ABP 798.
- ABP 798 (rituximab biosimilar) / Amgen, Allergan
A Randomized Double-Blind Study Comparing Pharmacokinetics (PK) and Pharmacodynamics (PD) of ABP 798 with Rituximab in Subjects with Moderate to Severe RA (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_1477;
Results of this study demonstrated PK similarity of ABP 798 to rituximab RP in subjects with moderate-to-severe RA. The PD of ABP 798 and rituximab RP were also found to be similar.
- ABP 798 (rituximab biosimilar) / Amgen, Allergan
Efficacy and Safety Results from a Randomized Double-Blind Study That Compared the Proposed Biosimilar ABP 798 with Rituximab in Subjects with Moderate to Severe RA (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_1475;
Based on the results of this study. clinical equivalence of ABP 798 to rituximab RP was established for efficacy and safety in subjects with moderate-to-severe RA.
- || ABP 798 (rituximab biosimilar) / Amgen, Allergan
Huge news for @Amgen and @Allergan today. #ABP798 https://t.co/vcdU9NfYEr #ITPaware (Twitter) - Aug 23, 2019
- | Riabni (rituximab-arrx) / Amgen, AbbVie
Trial completion: JASMINE: Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab (clinicaltrials.gov) - Jul 10, 2019
P3, N=256, Completed, Sponsor: Amgen
clinical equivalence of ABP 798 to rituximab RP was established for efficacy and safety in subjects with moderate-to-severe RA. Active, not recruiting --> Completed
- ||||| Riabni (rituximab-arrx) / Amgen, AbbVie
Enrollment closed: JASMINE: Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab (clinicaltrials.gov) - Jan 10, 2019
P3, N=250, Active, not recruiting, Sponsor: Amgen
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||||||| Riabni (rituximab-arrx) / Amgen, AbbVie
Trial completion: Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab (clinicaltrials.gov) - Oct 12, 2018
P3, N=311, Completed, Sponsor: Amgen
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||| Riabni (rituximab-arrx) / Amgen, AbbVie
Trial completion date, Trial primary completion date: JASMINE: Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab (clinicaltrials.gov) - Apr 30, 2018
P3, N=250, Recruiting, Sponsor: Amgen
Active, not recruiting --> Completed Trial completion date: Dec 2018 --> Apr 2019 | Trial primary completion date: Dec 2018 --> Apr 2019
- ||||| Riabni (rituximab-arrx) / Amgen, AbbVie
Enrollment closed: Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab (clinicaltrials.gov) - Nov 17, 2017
P3, N=311, Active, not recruiting, Sponsor: Amgen
Trial completion date: Dec 2018 --> Apr 2019 | Trial primary completion date: Dec 2018 --> Apr 2019 Recruiting --> Active, not recruiting
- |||| Riabni (rituximab-arrx) / Amgen, AbbVie
Trial primary completion date: JASMINE: Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab (clinicaltrials.gov) - Sep 1, 2017
P3, N=250, Recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting Trial primary completion date: Mar 2018 --> Dec 2018
- |||| Riabni (rituximab-arrx) / Amgen, AbbVie
Trial primary completion date: Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab (clinicaltrials.gov) - Mar 8, 2017
P3, N=300, Recruiting, Sponsor: Amgen
Trial primary completion date: Mar 2018 --> Dec 2018 Trial primary completion date: Aug 2017 --> Feb 2018
- |||||| Riabni (rituximab-arrx) / Amgen, AbbVie
Enrollment open: JASMINE: Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab (clinicaltrials.gov) - Jun 20, 2016
P3, N=250, Recruiting, Sponsor: Amgen
Trial primary completion date: Aug 2017 --> Feb 2018 Not yet recruiting --> Recruiting
- |||||||||| Riabni (rituximab-arrx) / Amgen, AbbVie
New P3 trial: Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab (clinicaltrials.gov) - Jun 9, 2016
P3, N=300, Recruiting, Sponsor: Amgen
- |||||||||| Riabni (rituximab-arrx) / Amgen, AbbVie
New P3 trial: JASMINE: Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab (clinicaltrials.gov) - Apr 21, 2016
P3, N=250, Not yet recruiting, Sponsor: Amgen